Device and method for unattended treatment of a patient

ABSTRACT

An unattended approach can increase the reproducibility and safety of the treatment as the chance of over/under treating of a certain area is significantly decreased. On the other hand, unattended treatment of uneven or rugged areas can be challenging in terms of maintaining proper distance or contact with the treated tissue, mostly on areas which tend to differ from patient to patient (e.g. facial area). Delivering energy via a system of active elements embedded in a flexible pad adhesively attached to the skin offers a possible solution. The unattended approach may include delivering of multiple energies to enhance a visual appearance.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/576,646, filed Jan. 14, 2022, which is a continuation of PCTApplication No. PCT/IB2021/00300, filed May 3, 2021, which claimspriority to U.S. Provisional Application No. 63/019,619, filed May 4,2020. All above mentioned applications are incorporated herein byreference in their entirety.

FIELD OF THE INVENTION

The present invention relates to methods and apparatus for patienttreatment by means of active elements delivering electromagnetic energyand/or secondary energy in such a way that the treatment area is treatedhomogeneously without the need for manipulation of the active elementsduring the therapy.

BACKGROUND OF THE INVENTION

Delivering various forms of electromagnetic energy into the patient formedical and cosmetic purposes has been widely used in the past. Thesecommon procedures include, but are by no means limited to, skinrejuvenation, wrinkle removal, skin tightening and lifting, celluliteand fat reduction, treatment of pigmented lesions, tattoo removal, softtissue coagulation and ablation, vascular lesion reduction, facelifting, muscle contractions and muscle strengthening, etc.

All of these procedures are performed to improve a visual appearance ofthe patient.

Besides many indisputable advantages of a thermal therapy, theseprocedures also bring certain limitations and associated risks. Amongothers is the limited ability of reproducible results as these arehighly dependent on applied treatment techniques and the operator'scapabilities. Moreover, if the therapy is performed inappropriately,there is an increased risk of burns and adverse events.

It is very difficult to ensure a homogeneous energy distribution if theenergy delivery is controlled via manual movement of the operator's handwhich is the most common procedure. Certain spots can be easily over- orunder-treated. For this reason, devices containing scanning or othermechanisms capable of unattended skin delivery have emerged. Thesedevices usually deliver energy without direct contact with the treatedarea, and only on a limited, well-defined area without apparentunevenness. Maintaining the same distance between the treated tissue andthe energy generator or maintaining the necessary tissue contact may bechallenging when treating uneven or rugged areas. Therefore, usage ofcommonly available devices on such specific areas that moreover differfrom patient to patient (e.g. the face) might be virtually impossible.

Facial unattended application is, besides the complications introducedby attachment to rugged areas and necessity of adaptation to the shapesof different patients, specific by its increased need for protectionagainst burns and other side effects. Although the face heals moreeasily than other body areas, it is also more exposed, leading to muchhigher requirements for treatment downtime. Another important aspect ofa facial procedure is that the face hosts the most important humansenses, whose function must not be compromised during treatment. Aboveall, eye safety must be ensured throughout the entire treatment.

The current aesthetic market offers either traditional manuallycontrolled radiofrequency or light devices enabling facial tissueheating to a target temperature in the range of 40° C.-100° C. orunattended LED facial masks whose operation is based on light effects(phototherapy) rather than thermal effects. These masks arepredominantly intended for home use and do not pose a risk to patientsof burns, overheating or overtreating. The variability in facial shapesof individual patients does not represent any issue for these masks asthe delivered energy and attained temperatures are so low that the riskof thermal tissue damage is minimized and there is no need forhomogeneous treatment. Also, due to low temperatures, it is notimportant for such devices to maintain the predetermined distancebetween the individual diodes and the patient's skin, and the shape ofthe masks is only a very approximate representation of the human face.But their use is greatly limited by the low energy and minimal to nothermal effect and they are therefore considered as a preventive toolfor daily use rather than a method of in-office skin rejuvenation withimmediate effect.

Nowadays, the aesthetic market feels the needs of the combination of theheating treatment made by electromagnetic energy delivered to theepidermis, dermis, hypodermis or adipose tissue with the secondaryenergy providing muscle contraction or muscle stimulation in the fieldof improvement of visual appearance of the patient. However, none of theactual devices is adapted to treat the uneven rugged areas like theface. In addition, the commercially available devices are usuallyhandheld devices that need to be operated by the medical professionalduring the whole treatment.

Thus it is necessary to improve medical devices providing more than onetreatment energy (e.g. electromagnetic energy and electric current),such that both energies may be deliver via different active elements orthe same active element (e.g. electrode). Furthermore, the applicator orpad of the device needs to be attached to the patient which allowsunattended treatment of the patient and the applicator or pad needs tobe made of flexible material allowing sufficient contact with the uneventreatment area of the body part of the patient.

SUMMARY OF THE INVENTION

In order to enable well defined unattended treatment of the uneven,rugged areas of a patient (e.g. facial area) while preserving safety,methods and devices of minimally invasive to non-invasiveelectromagnetic energy delivery via a single or a plurality of activeelements have been proposed.

The patient may include skin and a body part, wherein a body part mayrefer to a body area.

The desired effect of the improvement of visual appearance of thepatient may include tissue (e.g. skin) heating in the range of 40° C. to50° C., tissue coagulation at temperatures of 40° C. to 80° C. or tissueablation at temperatures of 60° C. to 100° C. Various patients and skinconditions may require different treatment approaches—highertemperatures allow better results with fewer sessions but require longerhealing times while lower temperatures enable treatment with no downtimebut limited results within more sessions. Another effect of the heatingmay lead to decreasing the number of the fat cells.

Another desired effect may be muscle contraction causing musclestimulation (e.g. strengthening or toning) for improving the visualappearance of the patient.

An arrangement for contact or contactless therapy has been proposed.

For contact therapy, the proposed device comprises at least oneelectromagnetic energy generator inside a main unit that generates anelectromagnetic energy which is delivered to the treatment area via atleast one active element attached to the skin. At least one activeelement may be embedded in a pad made of flexible material that adaptsto the shape of the rugged surface. An underside of the pad may includeof an adhesive layer allowing the active elements to adhere to thetreatment area and to maintain necessary tissue contact. Furthermore,the device may employ a safety system capable of adjusting one or moretherapy parameters based on the measured values from at least onesensor, e.g. thermal sensors or impedance measurement sensors capable ofmeasuring quality of contact with the treated tissue.

For contactless therapy, the proposed device comprises at least oneelectromagnetic energy generator inside a main unit that generates anelectromagnetic energy which is delivered to the treatment area via atleast one active element located at a defined distance from the tissueto be treated. A distance of at least one active element from thetreatment area may be monitored before, throughout the entire treatmentor post-treatment. Furthermore, the device may employ a safety systemcapable of adjusting one or more therapy parameters based on themeasured values from at least one sensor, for example one or moredistance sensors. Energy may be delivered by a single or a plurality ofstatic active elements or by moving a single or a plurality of activeelements throughout the entire treatment area, for example via abuilt-in automatic moving system, e.g. an integrated scanner. Treatmentareas may be set by means of laser sight—the operator may mark the areato be treated prior to the treatment.

The active element may deliver energy through its entire surface or bymeans of a so-called fractional arrangement when the active partincludes a matrix formed by points of defined size. These points may beseparated by inactive (and therefore untreated) areas that allow fastertissue healing. The points surface may make up from 1% to 99% of theactive element area.

The electromagnetic energy may be primarily generated by a laser, laserdiode module, LED, flash lamp or incandescent light bulb or byradiofrequency generator for causing the heating of the patient.Additionally, an acoustic energy or electric or electromagnetic energy,which does not heat the patient, may be delivered simultaneously,alternately or in overlap with the primary electromagnetic energy.

The active element may deliver more than one energy simultaneously (atthe same time), successively or in overlap. For example, the activeelement may deliver a radiofrequency energy and subsequently an electricenergy (electric current). In another example, the active element maydeliver the radiofrequency energy and the electric energy at the sametime.

Furthermore the device may be configured to deliver the electromagneticfield by at least one active element and simultaneously (at the sametime) to deliver e.g. electric energy by a different elements.

Thus the proposed methods and devices may lead to proper skinrejuvenation, wrinkle removal, skin tightening and lifting, celluliteand fat reduction, treatment of pigmented lesions, tattoo removal, softtissue coagulation and ablation, vascular lesions reduction, etc. ofuneven rugged areas without causing further harm to important parts ofthe patient's body, e.g. nerves or internal organs. The proposed methodand devices may lead to an adipose tissue reduction, e.g. by fat cellslipolysis or apoptosis.

Furthermore, the proposed methods and devices may lead to tissuerejuvenation, e. g. muscle strengthening or muscle toning through themuscle contraction caused by electric or electromagnetic energy.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a block diagram of an apparatus for contact therapy.

FIG. 2 is an illustration of an apparatus for contact therapy.

FIG. 3A represents pad shapes and layout.

FIG. 3B represents pad shapes and layout.

FIG. 4 represents a side view of the pad intended for contact therapy.

FIG. 5 shows one variant of energy delivery by switching multiple activeelements.

FIG. 6 shows a block diagram of an apparatus for contactless therapy.

FIG. 7 is an illustration of an apparatus for contactless therapy.

FIG. 8A is an illustration of the framed grated electrode.

FIG. 8B is an illustration of another framed grated electrode.

FIG. 8C is an illustration of framed grated electrode with thinningconductive lines.

FIG. 8D is an illustration of non-framed grated electrode.

FIG. 9 is an illustration of forehead applicator.

DETAILED DESCRIPTION

The presented methods and devices may be used for stimulation and/ortreatment of a tissue, including but not limited to skin, epidermis,dermis, hypodermis or muscles. The proposed apparatus is designed forminimally to non-invasive treatment of one or more areas of the tissueto enable well defined unattended treatment of the uneven, rugged areas(e.g. facial area) by electromagnetic energy delivery via a single or aplurality of active elements without causing further harm to importantparts of the patient's body, e.g. nerves or internal organs.

Additionally the presented methods and devices may be used to stimulatebody parts or body areas like head, neck, bra fat, love handles, torso,back, abdomen, buttocks, thighs, calves, legs, arms, forearms, hands,fingers or body cavities (e.g. vagina, anus, mouth, inner ear etc.).

The proposed methods and devices may include a several protocolsimproving of visual appearance, which may be preprogramed in the controlunit (e.g. CPU which may include a flex circuit or a printed circuitboard and may include a microprocessor or memory for controlling thedevice)).

The desired effect may include tissue (e.g. skin) heating (thermaltherapy) in the range of 37.5° C. to 65° C. or in the range of 38° C. to60° C. or in the range of 39° C. to 55° C. or in the range of 40° C. to50° C., tissue coagulation at temperatures in the range of 37.5° C. to95° C. or in the range of 38° C. to 90° C. or in the range of 39° C. to85° C. or in the range of 40° C. to 80° C. or tissue ablation attemperatures in the range of 50° C. to 130° C. or in the range of 55° C.to 120° C. or in the range of 60° C. to 110° C. or in the range of 60°C. to 100° C. The device may be operated in contact or in contactlessmethods. For contact therapy a target temperature of the skin may betypically within the range of 37.5° C. to 95° C. or in the range of 38°C. to 90° C. or in the range of 39° C. to 85° C. or in the range of 40°C. to 80° C. while for contactless therapy a target temperature of theskin may be in the range of 37.5° C. to 130° C. or in the range of 38°C. to 120° C. or in the range of 39° C. to 110° C. or in the range of40° C. to 100° C. The temperature within the range of 37.5° C. to 130°C. or in the range of 38° C. to 120° C. or in the range of 39° C. to110° C. or in the range of 40° C. to 100° C. may lead to stimulation offibroblasts and formation of connective tissue—e.g. collagen, elastin,hyaluronic acid etc. Depending on the target temperature, controlledtissue damage is triggered, physiological repair processes areinitiated, and new tissue is formed. Temperatures within the range of37.5° C. to 130° C. or in the range of 38° C. to 120° C. or in the rangeof 39° C. to 110° C. or in the range of 40° C. to 100° C. may furtherlead to changes in the adipose tissue. During the process of apoptosiscaused by high temperatures, fat cells come apart into apoptotic bodiesand are further removed via the process of phagocytosis. During aprocess called necrosis, fat cells are ruptured due to hightemperatures, and their content is released into an extracellularmatrix. Both processes may lead to a reduction of fat layers enablingreshaping of the face. Removing fat from the face may be beneficial forexample in areas like submentum or cheeks.

Another desired effect may include tissue rejuvenation, e. g. musclestrengthening through the muscle contraction caused by electric orelectromagnetic energy, which doesn't heat the patient, or the musclerelaxation caused by a pressure massage. The combined effect of musclecontractions via electric energy and tissue (e.g. skin) heating byelectromagnetic field in accordance to the description may lead tosignificant improvement of visual appearance.

FIG. 1 and FIG. 2 are discussed together. FIG. 1 shows a block diagramof an apparatus for contact therapy 1. FIG. 2 is an illustration of anapparatus for contact therapy 1. The apparatus for contact therapy 1 maycomprise two main blocks: main unit 2 and pad 4. Additionally, theapparatus 1 may comprise interconnecting block 3 or neutral electrode 7.However, the components of interconnecting block 3, may be implementedinto the main unit 2.

Main unit 2 may include one or more generators: a primaryelectromagnetic generator 6 which may preferably deliver radiofrequencyenergy in the range of 10 kHz to 300 GHz or 300 kHz to 10 GHz or 400 kHzto 6 GHz, or in the range of 100 kHz to 550 MHz or 250 kHz to 500 MHz or350 kHz to 100 MHz or 400 kHz to 80 MHz, a secondary generator 9 whichmay additionally deliver electromagnetic energy, which does not heat thepatient, or deliver electric current in the range of 1 Hz to 10 MHz or 5Hz to 5 MHz or in the range of 10 Hz to 1 MHz and/or an ultrasoundemitter 10 which may furthermore deliver an acoustic energy with afrequency in the range of 20 kHz to 25 GHz or 20 kHz to 1 GHz or 50 kHzto 250 MHz or 100 kHz to 100 MHz. In addition, the frequency of theultrasound energy may be in the range of 20 kHz to 80 MHz or 50 kHz to50 MHz or 150 kHz to 20 MHz.

The output power of the radiofrequency energy may be less than or equalto 450, 300, 250 or 220 W. Additionally, the radiofrequency energy onthe output of the primary electromagnetic generator 6 (e.g.radiofrequency generator) may be in the range of 0.1 W to 400 W, or inthe range of 0.5 W to 300 W or in the range of 1 W to 200 W or in therange of 10 W to 150 W. The radiofrequency energy may be applied in orclose to the ISM bands of 6.78 MHz, 13.56 MHz, 27.12 MHz, 40.68 MHz,433.92 MHz, 915 MHz, 2.45 GHz and 5.8 GHz.

Main unit 2 may further comprise a human machine interface 8 representedby a display, buttons, a keyboard, a touchpad, a touch panel or othercontrol members enabling an operator to check and adjust therapy andother device parameters. For example, it may be possible to set thepower, treatment time or other treatment parameters of each generator(primary electromagnetic generator 6, secondary generator 9 andultrasound emitter 10) independently. The human machine interface 8 maybe connected to CPU 11. The power supply 5 located in the main unit 2may include a transformer, disposable battery, rechargeable battery,power plug or standard power cord. The output power of the power supply5 may be in the range of 10 W to 600 W, or in the range of 50 W to 500W, or in the range of 80 W to 450 W.

Interconnecting block 3 may serve as a communication channel betweenmain unit 2 and pad 4. It may be represented by a simple devicecontaining basic indicators 17 and mechanisms for therapy control.Indicators 17 may be realized through the display, LEDs, acousticsignals, vibrations or other forms capable of providing adequate noticeto an operator and/or the patient. Indicators 17 may indicate actualpatient temperature, contact information or other sensor measurements aswell as a status of a switching process between the active elements,quality of contact with the treated tissue, actual treatment parameters,ongoing treatment, etc. Indicators 17 may be configured to warn theoperator in case of suspicious therapy behavior, e.g. temperature out ofrange, improper contact with the treated tissue, parametersautomatically adjusted etc. Interconnecting block 3 may be used as anadditional safety feature for heat-sensitive patients. It may containemergency stop button 16 so that the patient can stop the therapyimmediately anytime during the treatment. Switching circuitry 14 may beresponsible for switching between active elements or for regulation ofenergy delivery from primary electromagnetic generator 6, secondarygenerator 9 or ultrasound emitter 10. The rate of switching betweenactive elements 13 may be dependent on the amount of delivered energy,pulse length etc, and/or on the speed of switching circuitry 14 and CPU11. The switching circuitry 14 may include relay switch, transistor(bipolar, PNP, NPN, FET, JFET, MOSFET) thyristor, diod oropto-mechanical switch or any other suitable switch know in the priorart. The switching circuitry in connection with the CPU may control theswitching between the primary electromagnetic energy generated by theprimary electromagnetic generator 6 and the secondary energy generatedby the secondary generator 9 on the at least one active element.

Additionally, the interconnecting block 3 may contain the primaryelectromagnetic generator 6, the secondary generator 9 or ultrasoundemitter 10 or only one of them or any combination thereof.

The CPU 11 controls the primary electromagnetic generator 6 such thatthe primary electromagnetic energy may be delivered in a continuous mode(CM) or a pulse mode to the at least one active element, having afluence in the range of 10 mJ/cm² to 50 kJ/cm² or in the range of 100mJ/cm² to 10 kJ/cm² or in the range of 0.5 J/cm² to 1 kJ/cm². Theelectromagnetic energy may be primarily generated by a laser, laserdiode module, LED, flash lamp or incandescent light bulb or byradiofrequency generator for causing the heating of the patient. The CMmode may be operated for a time interval in the range of 0.05 s to 60min or in the range of 0.1 s to 45 min or in the range of 0.2 s to 30min. The pulse duration of the energy delivery operated in the pulseregime may be in the range of 0.1 ms to 10 s or in the range of 0.2 msto 7 s or in the range of 0.5 ms to 5 s. The primary electromagneticgenerator 6 in the pulse regime may be operated by CPU 11 in a singleshot mode or in a repetition mode. The frequency of the repetition modemay be in the range of 0.05 to 10 000 Hz or in the range of 0.1 to 5000Hz or in the range of 0.3 to 2000 Hz or in the range of 0.5 to 1000 Hz.Alternatively, the frequency of the repetition mode may be in the rangeof 0.1 kHz to 200 MHz or in the range of 0.5 kHz to 150 MHz or in therange of 0.8 kHz to 100 MHz or in the range of 1 kHz to 80 MHz. Thesingle shot mode may mean generation of just one electromagnetic pulseof specific parameters (e.g. intensity, duration, etc.) for delivery toa single treatment area. The repetition mode may mean generation of anelectromagnetic pulses, which may have the specific parameters (e.g.intensity, duration, etc.), with a repetition rate of theabove-mentioned frequency for delivery to a single treatment area. TheCPU 11 may provide treatment control such as stabilization of thetreatment parameters including treatment time, power, duty cycle, timeperiod regulating switching between multiple active elements,temperature of the device 1 and temperature of the primaryelectromagnetic generator 6 and secondary generator 9 or ultrasoundemitter 10. The CPU 11 may drive and provide information from theswitching circuitry 14. CPU 11 may also receive and provide informationfrom sensors located on or in the pad 4 or anywhere in the device 1. TheCPU 11 may include a flex circuit or a printed circuit board and mayinclude a microprocessor or memory for controlling the device.

The CPU 11 may control the secondary generator 9 such that secondaryenergy (e.g electric current or magnetic field) may be delivered in acontinuous mode (CM) or a pulse mode to the at least one active element,having a fluence in the range of 10 mJ/cm² to 50 kJ/cm² or in the rangeof 100 mJ/cm² to 10 kJ/cm² or in the range of 0.5 J/cm² to 1 kJ/cm² onthe surface of the at least one active element. Applying the secondaryenergy to the treatment area of the patient may cause a musclecontractions of the patient. The CM mode may be operated for a timeinterval in the range of 0.05 s to 60 min or in the range of 0.1 s to 45min or in the range of 0.2 s to 30 min. The pulse duration of thedelivery of the secondary energy operated in the pulse regime may be inthe range of 0.1 μs to 10 s or in the range of 0.2 μs to 1 s or in therange of 0.5 us to 500 ms. The secondary generator 9 in the pulse regimemay be operated by CPU 11 in a single shot mode or in a repetition mode.The frequency of the repetition mode may be in the range of 0.1 to 12000 Hz or in the range of 0.1 to 8000 Hz or in the range of 0.1 to 5000Hz or in the range of 0.5 to 1000 Hz.

The proposed device may be multichannel device allowing the CPU 11 tocontrol the treatment of more than one treated area at once.

Alternativelly, the interconnecting block 3 may not be a part of thedevice 1, and the CPU 11, switching circuitry 14, indicators 17 andemergency stop 16 may be a part of the main unit 2 or pad 4. Inaddition, some of the CPU 11, switching circuitry 14, indicators 17 andemergency stop 16 may be a part of the main unit 2 and some of them partof pad 4, e.g. CPU 11, switching circuitry 14 and emergency stop 16 maybe part of the main unit 2 and indicators 17 may be a part of the pad 4.

Pad 4 represents the part of the device which may be in contact with thepatient's skin during the therapy. The pads 4 may be made of flexiblesubstrate material—for example polymer-based material, polyimide (PI)films, teflon, epoxy, polyethylene terephthalate (PET), polyamide or PEfoam with an additional adhesive layer on an underside, e.g. ahypoallergenic adhesive gel or adhesive tape that may be bacteriostatic,non-irritating, or water-soluble. The substrate may also be asilicone-based substrate. The substrate may also be made of a fabric,e.g. non-woven fabric. The adhesive layer may have the impedance for acurrent at a frequency of 500 kHz in the range of 1 to 150 Ω or in therange of 5 to 130 Ω or in the range of 10 to 100 Ω, and the impedancefor a current at a frequency of 100 Hz or less is three times or morethe impedance for a current at a frequency of 500 kHz. The adhesivehydrogel may be made of a polymer matrix or mixture containing water, apolyhydric alcohol, a polyvinylpyrrolidone, a polyisocyanate component,a polyol component or has a methylenediphenyl structure in the mainchain. Additionally, a conductive adhesive may be augmented withmetallic fillers, such as silver, gold, copper, aluminum, platinum ortitanium or graphite that make up 1 to 90% or 2 to 80% or 5 to 70% ofadhesive. The adhesive layer may be covered by “ST-gel®” or “Tensive®”conductive adhesive gel which is applied to the body to reduce itsimpedance, thereby facilitating the delivery of an electric shock.

The adhesive layer under the pad 4 may mean that the adhesive layer isbetween the surface of the pad facing the patient and the body of thepatient. The adhesive layer may have impedance 1.1 times, 2 times, 4times or up to 10 times higher than the impedance of the skin of thepatient under the pad 4. A definition of the skin impedance may be thatit is a portion of the total impedance, measured between twoequipotential surfaces in contact with the epidermis, that is inverselyproportional to the electrode area, when the internal current flux pathis held constant. Data applicable to this definition would beconveniently recorded as admittance per unit area to facilitateapplication to other geometries. The impedance of the adhesive layer maybe set by the same experimental setup as used for measuring the skinimpedance. The impedance of the adhesive layer may be higher than theimpedance of the skin by a factor in the range of 1.1 to 20 times or 1.2to 15 times or 1.3 to 10 times.

The impedance of the adhesive layer may have a different values for thedifferent types of energy delivered to the patient, e.g. the impedancemay be different for radiofrequency and for electric current delivery.The impedance of the hydrogel may be in the range of 100 to 2000 Ohm orin the range of 150 to 1800 Ohm or 200 to 1500 Ohm or 300 to 1200 Ohm incase of delivery of the electric current (e.g. during electrotherapy)

The pad 4 may also have a sticker on a topside of the pad. The topsideis the opposite site of the underside (the side where the adhesive layermay be deposited) or in other words the top side is the side of the padthat is facing away from the patient during the treatment. The stickermay have a bottom side and a top side, wherein the bottom side of thesticker may comprise a sticking layer and the top side of the stickermay comprise non-sticking layer (eg. polyimide (PI) films, teflon,epoxy, polyethylene terephthalate (PET), polyamide or PE foam).

The sticker may have the same shape as the pad 4 or may have additionaloverlap over the pad. The sticker may be bonded to the pad such that thesticking layer of the bottom side of the sticker is facing towards thetopside of the pad 4. The top side of the sticker facing away from thepad 4 may be made of a non-sticking layer. The size of the sticker withadditional overlap may exceed the pad in the range of 0.1 to 10 cm, orin the range of 0.1 to 7 cm, or in the range of 0.2 to 5 cm, or in therange of 0.2 to 3 cm. This overlap may also comprise the sticking layerand may be used to form additional and more proper contact of the padwith the patient.

Alternatively, the pad 4 may comprise at least one suction opening, e.g.small cavities or slits adjacent to active elements or the activeelement may be embedded inside a cavity. The suction opening may beconnected via connecting tube to a pump which may be part of the mainunit 2. When the suction opening is brought into contact with the skin,the air sucked from the suction opening flows toward the connecting tubeand the pump and the skin may be slightly sucked into the suctionopening. Thus by applying a vacuum the adhesion of pad 4 may beprovided. Furthermore, the pad 4 may comprise the adhesive layer and thesuction openings for combined stronger adhesion.

In addition to the vacuum (negative pressure), the pump may also providea positive pressure by pumping the fluid to the suction opening. Thepositive pressure is pressure higher than atmospheric pressure and thenegative pressure or vacuum is lower than atmospheric pressure.Atmospheric pressure is a pressure of the air in the room during thetherapy.

The pressure (positive or negative) may be applied to the treatment areain pulses providing a massage treatment. The massage treatment may beprovided by one or more suction openings changing pressure value to thepatient's soft tissue in the meaning that the suction opening applydifferent pressure to patient tissue. Furthermore, the suction openingsmay create a pressure gradient in the soft tissue without touching theskin. Such pressure gradients may be targeted on the soft tissue layer,under the skin surface and/or to different soft tissue structure.

Massage accelerates and improves treatment therapy by electromagneticenergy, electric energy or electromagnetic energy which does not heatthe patient, improves blood and/or lymph circulation, angioedema,erythema effect, accelerates removing of the fat, accelerate metabolism,accelerates elastogenesis and/or neocolagenesis.

Each suction opening may provide pressure by a suction mechanism,airflow or gas flow, liquid flow, pressure provided by an objectincluded in the suction opening (e.g. massaging object, pressure cellsetc.) and/or in other ways.

Pressure value applied on the patient's tissue means that a suctionopening providing massaging effect applies positive, negative and/orsequentially changing positive and negative pressure on the treatedand/or adjoining patient's tissue structures and/or creates a pressuregradient under the patient's tissue surface

Massage applied in order to improve body liquid flow (e.g. lymphdrainage) and/or relax tissue in the surface soft tissue layers may beapplied with pressure lower than during the massage of deeper softtissue layers. Such positive or negative pressure compared to theatmospheric pressure may be in range of 10 Pa to 30 000 Pa, or in rangeof 100 Pa to 20 000 Pa or in range of 0.5 kPa to 19 kPa or in a range of1 kPa to 15 kPa.

Massage applied in order to improve body liquid flow and/or relaxationof the tissue in the deeper soft tissue layers may be applied withhigher pressure. Such positive or negative pressure may be in range from12 kPa to 400 kPa or from 15 kPa to 300 kPa or from 20 kPa to 200 kPa.An uncomfortable feeling of too high applied pressure may be used to seta pressure threshold according to individual patient feedback.

Negative pressure may stimulate body liquid flow and/or relaxation ofthe deep soft tissue layers (0.5 cm to non-limited depth in the softtissue) and/or layers of the soft tissue near the patient surface (0.1mm to 0.5 cm). In order to increase effectiveness of the massagenegative pressure treatment may be used followed by positive pressuretreatment.

A number of suction openings changing pressure values on the patient'ssoft tissue in one pad 4 may be between 1 to 100 or between 1 to 80 or 1to 40 or between 1 to 10.

Sizes and/or shapes of suction openings may be different according totreated area. One suction opening may cover an area on the patientsurface between 0.1 mm2 to 1 cm2 or between 0.1 mm2 to 50 mm2 or between0.1 mm2 to 40 mm2 or between 0.1 mm2 to 20 mm2. Another suction openingmay cover an area on the patient surface between 1 cm2 to 1 m2 orbetween 1 cm2 to 100 cm2 or between 1 cm2 to 50 cm2 or between 1 cm2 to40 cm2.

Several suction openings may work simultaneously or switching betweenthem may be in intervals between 1 ms to 10 s or in intervals between 10ms to 5 s or in intervals between 0.5 s to 2 s.

Suction openings in order to provide massaging effect may be guidedaccording to one or more predetermined massage profile included in theone or more treatment protocols. The massage profile may be selected bythe operator and/or by a CPU with regard to the patient's condition. Forexample a patient with lymphedema may require a different level ofcompression profile and applied pressure than a patient with a healedleg ulcer.

Pressure applied by one or more suction openings may be graduallyapplied preferably in the positive direction of the lymph flow and/orthe blood flow in the veins. According to specific treatment protocolsthe pressure may be gradually applied in a direction opposite ordifferent from ordinary lymph flow. Values of applied pressure duringthe treatment may be varied according to the treatment protocol.

A pressure gradient may arise between individual suction openings.Examples of gradients described are not limited for this method and/ordevice. The setting of the pressure gradient between at least twoprevious and successive suction openings may be: 0%, i.e. The appliedpressure by suction openings is the same (e.g. pressure in all suctionopenings of the pad is the same);

1%, i.e. The applied pressure between a previous and a successivesuction opening decreases and/or increases with a gradient of 1% (e.g.the pressure in the first suction opening is 5 kPa and the pressure inthe successive suction opening is 4.95 kPa);

2%, i.e. The pressure decreases or increases with a gradient of 2%. Thepressure gradient between two suction openings may be in range 0% to100% where 100% means that one suction openings is not active and/ordoes not apply any pressure on the patient's soft tissue.

A treatment protocol that controls the application of the pressuregradient between a previous and a successive suction opening may be inrange between 0.1% to 95%, or in range between 0.1% to 70%, or in rangebetween 1% to 50%.

The suction opening may also comprise an impacting massage objectpowered by a piston, massage object operated by filling or sucking outliquid or air from the gap volume by an inlet/outlet valve or massageobject powered by an element that creates an electric field, magneticfield or electromagnetic field. Additionally, the massage may beprovided by impacting of multiple massage objects. The multiple massageobjects may have the same or different size, shape, weight or may becreated from the same or different materials. The massage objects may beaccelerated by air or liquid flowing (through the valve) or by anelectric, magnetic or electromagnetic field. Trajectory of the massageobjects may be random, circular, linear and/or massage objects mayrotate around one or more axes, and/or may do other types of moves inthe gap volume.

The massage unit may also comprise a membrane on the side facing thepatient which may be accelerated by an electric, magnetic,electromagnetic field or by changing pressure value in the gap volumebetween wall of the chamber and the membrane. This membrane may act asthe massage object.

During the treatment, it may be convenient to use a combination of padswith adhesive layer and pads with suction openings. In that case atleast one pad used during the treatment may comprise adhesive layer andat least additional one pad used during the treatment may comprisesuction opening. For example, pad with adhesive layer may be suited fortreatment of more uneven areas, e.g. periorbital area, and pad withsuction openings for treatment of smoother areas, e.g. cheeks.

The advantage of the device where the attachment od the pads may beprovided by adhesion layer or by suction opening or their combination isthat there is no need of any additional gripping system which would benecessary to hold the pads on the treatment area during the treatment,e.g. a band or a felt, which may cause a discomfort of the patient.

Yet in another embodiment, it is possible to fasten the flexible pads 4to the face by at least one band or felt which may be made from anelastic material and thus adjusted for an individual face. In that casethe flexible pads, which may have not the adhesive layer or suctionopening, are placed on the treatment area of the patient and theirposition is then fastened by a band or felt to avoid deflection of thepads from the treatment areas. Alternatively, the band may be replacedby an elastic mask that covers from 5% to 100% or from 30% to 99% orfrom 40% to 95% or from 50% to 90% of the face and may serve to securethe flexible pads on the treatment areas. Furthermore, it may bepossible to use the combination of the pad with adhesive layer orsuction opening and the fastening band, felt or mask to ensure strongattachment of the pads on the treatment areas.

Additionally, the fastening mechanism may be in the form of a textile ora garment which may be mountable on a user's body part. In use of thedevice, a surface of the electrode or electrode pad 4 lays along aninner surface of the garment, while the opposite surface of theelectrode or electrode pad 4 is in contact with the user's skin,preferably by means of a skin-electrode hydrogel interface.

The garment may be fastened for securement of the garment to or around auser's body part, e.g. by hook and loop fastener, button, buckle, stud,leash or cord, magnetic-guided locking system or clamping band and thegarment may be manufactured with flexible materials or fabrics thatadapt to the shape of the user's body or limb. The electrode pad 4 maybe in the same way configured to be fastened to the inner surface of thegarment. The garment is preferably made of breathable materials. Nonlimiting examples of such materials are soft Neoprene, Nylon,polyurethane, polyester, polyamide, polypropylene, silicone, cotton orany other material which is soft and flexible. All named materials couldbe used as woven, non-woven, single use fabric or laminated structures.

The garment and the pad may be modular system, which means module orelement of the device (pad, garment) and/or system is designedseparately and independently from the rest of the modules or elements,at the same time that they are compatible with each other.

The pad 4 may be designed to be attached to or in contact with thegarment, thus being carried by the garment in a stationary or fixedcondition, in such a way that the pads are disposed on fixed positionsof the garment. The garment ensures the correct adhesion or dispositionof the pad to the user's skin. In use of the device, the surface of oneor more active elements not in contact with the garment is in contactwith the patient's skin, preferably by means of a hydrogel layer thatacts as pad-skin interface. Therefore, the active elements included inthe pad are in contact with the patient's skin.

The optimal placement of the pad on the patient's body part, andtherefore the garment which carries the pad having the active elements,is determined by a technician or clinician helping the patient.

In addition, the garment may comprise more than one pad or the patientmay wear more than one garment comprising one or more pads during onetreatment session.

The pad 4 may contain at least one active element 13 capable ofdelivering energy from primary electromagnetic generator 6 or secondarygenerator 9 or ultrasound emitter 10. The active element may be in theform of an electrode, an optical element, an acoustic window, anultrasound emitter or other energy delivering elements known in the art.The electrode may be a radiofrequency (RF) electrode. The RF electrodemay be a dielectric electrode coated with insulating (e.g. dielectric)material. The RF electrode may be monopolar, bipolar, unipolar ormultipolar. The bipolar arrangement may consist of electrodes thatalternate between active and return function and where the thermalgradient beneath electrodes is almost the same during treatment. Bipolarelectrodes may form circular or ellipsoidal shapes, where electrodes areconcentric to each other. However, a group of bipolar electrode systemsmay be used as well. A unipolar electrode or one or more multipolarelectrodes may be used as well. The system may alternatively usemonopolar electrodes, where the so called return electrode has largerarea than so called active electrode. The thermal gradient beneath theactive electrode is therefore higher than beneath the return electrode.The active electrode may be part of the pad and the passive electrodehaving larger surface area may be located at least 5 cm, 10 cm, or 20 cmfrom the pad. A neutral electrode may be used as the passive electrode.The neutral electrode may be on the opposite side of the patient's bodythan the pad is attached. A unipolar electrode may also optionally beused. During unipolar energy delivery there is one electrode, no neutralelectrode, and a large field of RF emitted in an omnidirectional fieldaround a single electrode. Capacitive and/or resistive electrodes may beused. Radiofrequency energy may provide energy flux on the surface ofthe active element 13 or on the surface of the treated tissue (e.g.skin) in the range of 0.001 W/cm² to 1500 W/cm² or 0.01 W/cm² to 1000W/cm² or 0.5 W/cm² to 500 W/cm² or 0.5 W/cm² to 100 W/cm² or 1 W/cm² to50 W/cm². The energy flux on the surface of the active element 13 may becalculated from the size of the active element 13 and its output valueof the energy. The energy flux on the surface of the treated tissue maybe calculated from the size of the treated tissue exactly below theactive element 13 and its input value of the energy provided by theactive element 13. In addition, the RF electrode positioned in the pad 4may act as an acoustic window for ultrasound energy.

The active element 13 may provide a secondary energy from secondarygenerator 9 in form of an electric current or a magnetic field. Byapplying the secondary energy to the treated area of the body of thepatient, muscle fibers stimulation may be achieved and thus increasingmuscle tone, muscle strengthening, restoration of feeling the muscle,relaxation of the musculature and/or stretching musculature.

The proposed device may provide an electrotherapy in case that thesecondary energy delivered by the active element 13 (e.g aradiofrequency electrode or simply referred just as an electrode) is theelectric current. The main effects of electrotherapy are: analgesic,myorelaxation, iontophoresis, anti-edematous effect or musclestimulation causing a muscle fiber contraction. Each of these effectsmay be achieved by one or more types of electrotherapy: galvaniccurrent, pulse direct current and alternating current.

Galvanic current (or “continuous”) is a current that may have constantelectric current and/or absolute value of the electric current is inevery moment higher than 0. It may be used mostly for iontophoresis, orits trophic stimulation (hyperemic) effect is utilized. At the presentinvention this current may be often substituted by galvanic intermittentcurrent. Additionally, galvanic component may be about 95% but due tointerruption of the originally continuous intensity the frequency mayreach 5-12 kHz or 5-10 kHz or 5-9 kHz or 5-8 kHz.

The pulse direct current (DC) is of variable intensity but only onepolarity. The basic pulse shape may vary. It includes e.g. diadynamics,rectangular, triangular and exponential pulse of one polarity. Dependingon the used frequency and intensity it may have stimulatory, tropic,analgesic, myorelaxation, iontophoresis, at least partial musclecontraction and anti-edematous effect and/or other.

Alternating Current (AC or biphasic) where the basic pulse shape mayvary—rectangular, triangular, harmonic sinusoidal, exponential and/orother shapes and/or combination of mentioned above. It can bealternating, symmetric and/or asymmetric. Use of alternating currents incontact electrotherapy implies much lower stress on the tissue under theelectrode. For these types of currents the capacitive component of skinresistance is involved, and due to that these currents are very welltolerated by the patients.

AC therapies may be differentiate to five subtypes: TENS, Classic(four-pole) Interference, Two-pole Interference, Isoplanar Interferenceand Dipole Vector Field. It also exist some specific electrotherapyenergy variants and modularity of period, shape of the energy etc.

Due to interferential electrotherapy, different nerves and tissuestructures by medium frequency may be stimulated in a range of 500 Hz to12 kHz or in a range of 500 Hz to 8 kHz, or 500 Hz to 6 kHz, creatingpulse envelopes with frequencies for stimulation of the nerves andtissues e.g. sympathetic nerves (0.1-5 Hz), parasympathetic nerves(10-150 Hz), motor nerves (10-50 Hz), smooth muscle (0.1-10 Hz), sensornerves (90-100 Hz) nociceptive fibres (90-150 Hz).

Electrotherapy may provide stimulus with currents of frequency in therange from 0.1 Hz to 12 kHz or in the range from 0.1 Hz to 8 kHz or inthe range from 0.1 Hz to 6 kHz.

Muscle fiber stimulation by electrotherapy may be important duringand/or as a part of the RF treatment. Muscle stimulation increases bloodflow and lymph circulation. It may improve removing of treated cellsand/or prevent of hot spots creation. Moreover internal massagestimulation of adjoining tissues improves homogeneity of tissue anddispersing of the delivered energy. The muscle fiber stimulation byelectrotherapy may cause muscle contractions, which may lead toimprovement of a visual appearance of the patient through muscle firmingand strenghtening, Another beneficial effect is for example during fatremoving with the RF therapy. RF therapy may change structure of the fattissue. The muscle fiber stimulation may provide internal massage, whichmay be for obese patient more effective than classical massage.

Muscle stimulation may be provided by e.g. intermittent direct currents,alternating currents (medium-frequency and TENS currents), faradiccurrent as a method for multiple stimulation and/or others.

Frequency of the currents may be in the range from 0.1 Hz to 1500 Hz orfrom 0.1 to 1000 Hz or from 0.1 Hz to 500 Hz or from 0.1 to 300 Hz.

Frequency of the current envelope is typically in the range from 0.1 Hzto 500 Hz or from 0.1 to 250 Hz or from 0.1 Hz to 150 Hz or from 0.1 to140 Hz.

The electrostimulation may be provided in a combined manner wherevarious treatments with various effects may be achieved. As anillustrative example, the electromagnetic energy with theelectrostimulation may be dosed in trains of pulses of electric currentwhere the first train of electrostimulation may achieve different effectthan second or other successive train of stimulation. Therefore, thetreatment may provide muscle fibers stimulation or muscle contractionsfollowed by relaxation, during continual or pulsed radiofrequencythermal heating provided by electromagnetic energy provided byelectromagnetic energy generator.

The electrostimulation may be provided by monopolar, unipolar, bipolaror multipolar mode.

Absolute value of voltage between the electrotherapy electrodes operatedin bipolar, multipolar mode (electric current flow between more than twoelectrodes) and/or provided to at least one electrotherapy electrode maybe in range between 0.8 V and 10 kV; or in range between 1 V and 1 kV;or in range between 1 V and 300 V or in range between 1 V and 100 V.

Current density of electrotherapy for non-galvanic current may be inrange between 0.1 mA/cm² and 150 mA/cm², or in range between 0.1 mA/cm²and 100 mA/cm², or in range between 0.1 mA/cm² and 50 mA/cm², or inrange between 0.1 mA/cm² and 20 mA/cm²; for galvanic current may bepreferably in range between 0.05 mA/cm² and 3 mA/cm², or in rangebetween 0.1 mA/cm² and 1 mA/cm²,or in range between 0.01 mA/cm² and 0.5mA/cm². The current density may be calculated on the surface of theelectrode providing the electrotherapy to the patient.

During electrotherapy, e.g. bipolar electrotherapy, two or moreelectrodes may be used. If polarity of at least one electrode has anon-zero value in a group of the electrodes during bipolar mode, thegroup of the electrodes has to include at least one electrode withopposite polarity value. Absolute values of both electrode polaritiesmay or may not be equal. In bipolar electrostimulation mode stimulatingsignal passes through the tissue between electrodes with oppositepolarities.

Distance between two electrodes operating in bipolar mode may be inrange between 0.1 mm and 4 cm or in range between 0.2 mm to 3 cm or inrange between 0.5 mm and 2 cm or in range between 1 mm and 1 cm or inthe range of 0.1 cm and 40 cm or in range between 1 cm and 30 cm, or inthe range between 1 cm and 20 cm.

During monopolar electrotherapy mode stimulating signal may be inducedby excitement of action potential by changing polarity of one electrodethat change polarization in the nerve fiber and/or neuromuscular plague.

During the electrotherapy, one of the bipolar or monopolarelectrotherapy mode may be used or bipolar or monopolar electrotherapymode may be combined.

The ultrasound emitters may provide focused or defocused ultrasoundenergy. The ultrasound energy may be transferred to the tissue throughan acoustic window. The output power of the ultrasound energy on thesurface of the active element 13 may be less than or equal to 20 W or 15W or 10 W or 5 W. Ultrasound energy may provide energy flux on thesurface of the active element 13 or on the surface of the treated tissue(e.g. skin) in the range of 0.001 W/cm² to 250 W/cm², or in the range of0.005 W/cm² to 50 W/cm², or in the range of 0.01 W/cm² to 25 W/cm², orin the range of 0.05 W/cm² to 20 W/cm². The treatment depth ofultrasound energy may be in the range of 0.1 mm to 100 mm or 0.2 mm to50 mm or 0.25 mm to 25 mm or 0.3 mm to 15 mm. At a depth of 5 mm theultrasound energy may provide an energy flux in the range of 0.01 W/cm²to 20 W/cm² or 0.05 W/cm² to 15 W/cm². An ultrasound beam may have abeam non-uniformity ratio (RBN) in the range of 0.1 to 20 or 2 to 15 to4 to 10. In addition, an ultrasound beam may have a beam non-uniformityratio below 15 or below 10. An ultrasound beam may be divergent,convergent and/or collimated. The ultrasound energy may be transferredto the tissue through an acoustic window. It is possible that the RFelectrode may act as the acoustic window. Furthermore, the ultrasoundemitter 10 may be a part of the active element 13, thus ultrasoundemitter 10 may be a part of the pad 4.

At least some of the active elements 13 may be capable of deliveringenergy from primary electromagnetic generator 6 or secondary generator 9or ultrasound emitter 10 simultaneously (at the same time) successivelyor in an overlapping method or in any combination thereof. For example,the active element 13 may be capable of delivering radiofrequency energyand electric current sequentially, which may mean that firstly theactive element 13 may provide primary electromagnetic energy generatedby the primary electromagnetic generator 6 and subsequently the activeelement 13 may provide the secondary energy generated by the secondarygenerator 9. Thus the active element 13 may e.g. apply radiofrequencyenergy to the tissue of the patient and then the same active element 13may apply e.g. electrical current to the tissue of the patient.

Pad 4 may further comprise thermal sensors 15 enabling temperaturecontrol during the therapy, providing feedback to CPU 11, enablingadjustment of treatment parameters of each active element and providinginformation to the operator. The thermal sensor 15 may be a contactsensor, contactless sensor (e.g. infrared temperature sensor) orinvasive sensor (e.g. a thermocouple) for precise temperaturemeasurement of deep layers of skin, e.g. epidermis, dermis orhypodermis. The CPU 11 may also use algorithms to calculate the deep orupper-most temperatures. A temperature feedback system may control thetemperature and based on set or pre-set limits alert the operator inhuman perceptible form, e.g. on the human machine interface 8 or viaindicators 17. In a limit temperature condition, the device may beconfigured to adjust one or more treatment parameters, e.g. outputpower, switching mode, pulse length, etc. or stop the treatment. A humanperceptible alert may be a sound, alert message shown on human machineinterface 8 or indicators 17 or change of color of any part of theinterconnecting block 3 or pad 4.

Memory 12 may include, for example, information about the type and shapeof the pad 4, its remaining lifetime, or the time of therapy that hasalready been performed with the pad.

Neutral electrode 7 may ensure proper radiofrequency distribution withinthe patient's body for mono-polar radiofrequency systems. The neutralelectrode 7 is attached to the patient's skin prior to each therapy sothat the energy may be distributed between active element 13 and neutralelectrode 7. In some bipolar or multipolar radiofrequency systems, thereis no need to use a neutral electrode—radiofrequency energy isdistributed between multiple active elements 13. Neutral electrode 7represents an optional block of the apparatus 1 as any type ofradiofrequency system can be integrated.

Additionally, device 1 may include one or more sensors. The sensor mayprovide information about at least one physical quantity and itsmeasurement may lead to feedback which may be displayed by human machineinterface 8 or indicators 17. The one or more sensors may be used forsensing delivered electromagnetic energy, impedance of the skin,resistance of the skin, temperature of the treated skin, temperature ofthe untreated skin, temperature of at least one layer of the skin, watercontent of the device, the phase angle of delivered or reflected energy,the position of the active elements 13, the position of theinterconnecting block 3, temperature of the cooling media, temperatureof the primary electromagnetic generator 6 and secondary generator 9 andultrasound emitter 10 or contact with the skin. The sensor may be athermal, acoustic, vibration, electric, magnetic, flow, positional,optical, imaging, pressure, force, energy flux, impedance, current, Hallor proximity sensor. The sensor may be a capacitive displacement sensor,acoustic proximity sensor, gyroscope, accelerometer, magnetometer,infrared camera or thermographic camera. The sensor may be invasive orcontactless. The sensor may be located on or in the pad 4, in the mainunit 2, in the interconnecting block 3 or may be a part of a thermalsensor 15. One sensor may measure more than one physical quantity. Forexample, the sensor may include a combination of a gyroscope, anaccelerometer and/or a magnetometer. Additionally, the sensor maymeasure one or more physical quantities of the treated skin or untreatedskin.

A resistance sensor may measure skin resistance, because skin resistancemay vary for different patients, as well as the humidity—wetness andsweat may influence the resistance and therefore the behavior of theskin in the energy field. Based on the measured skin resistance, theskin impedance may also be calculated.

Information from one or more sensors may be used for generation of apathway on a model e.g. a model of the human body shown on a display ofhuman machine interface 8. The pathway may illustrate a surface orvolume of already treated tissue, presently treated tissue, tissue to betreated, or untreated tissue. A model may show a temperature map of thetreated tissue providing information about the already treated tissue oruntreated tissue.

The sensor may provide information about the location of bones, inflamedtissue or joints. Such types of tissue may not be targeted byelectromagnetic energy due to the possibility of painful treatment.Bones, joints or inflamed tissue may be detected by any type of sensorsuch as an imaging sensor (ultrasound sensor, IR sensor), impedancesensor, and the like. A detected presence of these tissue types maycause general human perceptible signals or interruption of generation ofelectromagnetic energy. Bones may be detected by a change of impedanceof the tissue or by analysis of reflected electromagnetic energy.

The patient's skin over at least one treatment portion may be pre-cooledto a selected temperature for a selected duration, the selectedtemperature and duration for pre-cooling may be sufficient to cool theskin to at least a selected temperature below normal body temperature.The skin may be cooled to at least the selected temperature to a depthbelow the at least one depth for the treatment portions so that the atleast one treatment portion is substantially surrounded by cooled skin.The cooling may continue during the application of energy, and theduration of the application of energy may be greater than the thermalrelaxation time of the treatment portions. Cooling may be provided byany known mechanism including water cooling, sprayed coolant, presenceof an active solid cooling element (e.g. thermoelectric cooler) or airflow cooling. A cooling element may act as an optical element.Alternatively, the cooling element may be a spacer. Cooling may beprovided during, before or after the treatment with electromagneticenergy. Cooling before treatment may also provide an environment forsudden heat shock, while cooling after treatment may provide fasterregeneration after heat shock. The temperature of the coolant may be inthe range of −200° C. to 36° C. The temperature of the cooling elementduring the treatment may be in the range of −80° C. to 36° C. or −70° C.to 35° C. or −60° C. to 34° C. Further, where the pad is not in contactwith the patient's skin, cryogenic spray cooling, gas flow or othernon-contact cooling techniques may be utilized. A cooling gel on theskin surface might also be utilized, either in addition to or insteadof, one of the cooling techniques indicated above.

FIG. 3A and FIG. 3B show different shapes and layouts of pad 4 used byan apparatus for contact therapy. Pads 4 comprise at least one activeelement 13 and may be available in various shapes and layouts so thatthey may cover a variety of different treatment areas and accommodateindividual patient needs, e.g. annular, semicircular, elliptical,oblong, square, rectangular, trapezoidal, polygonal or formless (havingno regular form or shape). The shapes and layouts of the pad 4 may beshaped to cover at least part of one or more of the periorbital area,the forehead (including frown lines), the jaw line, the perioral area(including Marionette lines, perioral lines—so called smoker lines,nasolabial folds, lips and chin), cheeks or submentum, etc. The shape ofthe pad 4 and distribution, size and number of active elements 13 maydiffer depending on the area being treated, e.g. active elements 13inside the pad 4 may be in one line, two lines, three lines, four linesor multiple lines. The pad 4 with active elements 13 may be arrangedinto various shapes, e.g. in a line, where the centers of at least twoactive elements 13 lie in one straight line, while any additional centerof an active element 13 may lie in the same or different lines insidethe pad 4.

In addition, the pad 4 may be used to treat at least partially neck, brafat, love handles, torso, back, abdomen, buttocks, thighs, calves, legs,arms, forearms, hands, fingers or body cavities (e.g. vagina, anus,mouth, inner ear etc.).

The pad 4 may have a rectangular, oblong, square, trapezoidal form, orof the form of a convex or concave polygon wherein the pad 4 may have atleast two different inner angles of the convex or concave polygonstructure. Additionally, the pad 4 may form at least in part the shapeof a conic section (also called conic), e.g. circle, ellipse, parabolaor hyperbola. The pad 4 may have at least in part one, two, three, four,five or more curvatures of a shape of an arc with the curvature k in therange of 0.002 to 10 mm⁻¹ or in the range of 0.004 to 5 mm⁻¹ or in therange of 0.005 to 3 mm⁻¹ or in the range of 0.006 to 2 mm⁻¹. The pad 4may have at least one, two, three, four, five or more arcs with thecurvature k or may have at least two different inner angles of a convexor concave polygon structure, and may be suitable for the treatment ofchin, cheeks, submental area (e.g. “banana shape 1” 4.2), for treatingjaw line, perioral area, Marionette lines and nasolabial folds (e.g.“banana shape 2” 4.4), for the treatment of periorbital area (e.g.“horseshoe shape” 4.3) or other regions of face and neck. The “bananashape” pad 4.2 or 4.4 may have a convex-concave shape, which means thatone side is convex and the opposite side is concave, that occupies atleast 5% to 50% or 10% to 60% or 15% to 70% or 20% to 90% of a totalcircumference of the pad 4 seen from above, wherein the shortestdistance between the endpoints 4.21 a and 4.21b of the “banana shape”pad 4.2 (dashed line in FIG. 3A) is longer than the shortest distancebetween the endpoint 4.21 a or 4.21b and the middle point 4.22 of the“banana shape” (full line in pad 4.2 in FIG. 3A). The “horseshoe shape”4.3 seen from above may have the convex-concave shape that occupies atleast 15% to 50% or 20% to 60% or 25% to 70% or 30% to 90% of its totalcircumference, wherein the shortest distance between the endpoints 4.31a and 4.31b of the “horseshoe shape” pad 4.3 (dashed line in FIG. 3B) isequal or shorter than the shortest distance between the endpoint 4.31 aor 4.31b and the middle point 4.32 of the “horseshoe shape” (full linein pad 4.3 in FIG. 3B). When seen from above, if the longest possiblecenter curve, which may be convex or concave and whose perpendiculars ata given point have equidistant distance from perimeter edges of the padat each of its points (dotted line in pad 4.2 in FIG. 3A), intersectsthe circumference of the pad 4 then this point is the endpoint of thepad, e.g. endpoint 4.21 a or 4.21b. The middle point, e.g. 4.22, is thengiven as the middle of the center curve, wherein the total length of thecenter curve is given by two endpoints, e.g. 4.21 a and 4.21 b, thus thelength of the center curve (dotted line in pad 4.2 in FIG. 3A) frompoint 4.21 a to point 4.22 is the same as the length from point 4.21 bto point 4.22. The total length of the center curve may be in the rangeof 0.1 to 30 cm or in the range of 0.5 to 25 cm or in the range of 1 to20 cm.

In addition, the center curve may have at least in part circular,elliptical, parabolic, hyperbolic, exponential, convex or concave curvesuch that the straight line connecting endpoint of the pad 4 with themiddle point of the center curve forms an angle alpha with the tangentof the middle of the center curve. The angle alpha may be in a range of0.1° to 179° or in a range of 0.2° to 170° or in a range of 0.5° to 160°or in a range of 1° to 150°.

The pad 4 whose shape has at least two concave arcs with the curvature kor has at least two concave inner angles of the polygon structure may besuitable for the treatment of the forehead like the “T shape” 4.1 inFIG. 3A. The “T shape” 4.1 may be also characterized by the arrangementof the active elements 13 where the centers of at least two activeelements 13 lie in one straight line and center of at least oneadditional element 13 lies in a different line.

Pads may have different sizes with the surface areas ranging from 0.1 to150 cm² or from 0.2 to 125 cm² or from 0.5 to 100 cm² or in the range of1 to 50 cm². The pad may occupy approximately 1 to 99% or 1 to 80% or 1to 60% or 1 to 50% of the face. The number of active elements 13 withina single pad 4 ranges from 1 to 100 or from 1 to 80 or from 1 to 60 orfrom 1 to 40. A thickness at least in a part of the pad 4 may be in therange of 0.01 to 15 cm or in the range of 0.02 to 10 cm or in the rangeof 0.05 to 7 cm or in the range of 0.1 to 7 cm.

Furthermore the pads 4 may have a shape that at least partiallyreplicates the shape of galea aponeurotica, procerus, levatar labiisuperioris alaeque nasi, nasalis, lavator labii superioris, zygomaticusminor, zygomaticus major, levator angulis oris, risorius, platysma,depressor anguli oris, depressor labii inferioris, occipitofrontalis(frontal belly), currugator supercilii, orbicularis oculi, buccinator,masseter, orbicularis oris or mentalis muscle when the pad 4 is attachedto the surface of the patient skin.

The pad 4 may be characterized by at least one aforementioned aspect orby a combination of more than one aforementioned aspect or by acombination of all aforementioned aspects.

The electromagnetic energy generator 6 or the secondary generator 9inside the main case may generate an electromagnetic or secondary energy(e.g. electric current) which may be delivered via a conductive lead toat least one active element 13 attached to the skin, respectively. Theactive element 13 may deliver energy through its entire surface or bymeans of a so-called fractional arrangement. Active element 13 maycomprise an active electrode in a monopolar, unipolar, bipolar ormultipolar radiofrequency system. In the monopolar radiofrequencysystem, energy is delivered between an active electrode (active element13) and a neutral electrode 7 with a much larger surface area. Due tomutual distance and difference between the surface area of the activeand neutral electrode, energy is concentrated under the active electrodeenabling it to heat the treated area. In the unipolar, bipolar ormultipolar radiofrequency system, there is no need for neutral electrode7. In the bipolar and multipolar radiofrequency system, energy isdelivered between two and multiple active electrodes with similarsurface area, respectively. The distance between these electrodesdetermines the depth of energy penetration. In the unipolarradiofrequency system, only a single active electrode is incorporatedand energy is delivered to the tissue and environment surrounding theactive electrode. The distance between the two nearest active elements13 (e.g. the nearest neighboring sides of electrodes) in one pad 4 maybe in the range of 0.1 to 100 mm or in the range of 0.3 to 70 mm or inthe range of 0.5 to 60 mm or in the range of 1 to 50 mm.

FIG. 4 represents a side view of the pad 4 configured for contacttherapy. Pads 4 may be made of flexible substrate material 42—polyimide(PI) films, teflon, epoxy or PE foam with an additional adhesive layer40 on the underside. They may be of different shapes to allow theoperator to choose according to the area to be treated. Active elements13 may have a circumference of annular, semicircular, elliptical,oblong, square, rectangular, trapezoidal or polygonal shape with asurface area in the range from 0.1 to 70 cm² or from 0.5 to 50 cm² orfrom 1 to 25 cm² or from 1 to 10 cm². The material used may be copper,aluminum, lead or any other conductive medium that can be deposited orintegrated in the pad. Furthermore the active elements 13 (e.g.electrodes) may be made of silver, gold or graphite. Electrodes 13 inthe pad 4 may be printed by means of biocompatible ink, such as silverink, graphite ink or a combination of inks of different conductivematerials.

The active element 13 (e.g. electrode providing radiofrequency fieldand/or electric field) may be full-area electrode that has a full activesurface. This means that the whole surface of the electrode facing thepatient may be made of conductive material deposited or integrated inthe pad 4 as mentioned above.

Alternatively, the surface of the electrode 13 facing the patient may beformed by the combination of the conductive (e.g. copper) andnon-conductive material (for example dielectric material, insulationmaterial, substrate of the pad, air or hydrogel). The electrode 13 maybe framed by the conductive material and the inside of the frame mayhave a combination of conductive and non-conductive material. The framemay create the utmost circumference of the electrode from the sidefacing the patient. The frame may have a form of annular, semicircular,elliptical, oblong, square, rectangular, trapezoidal or polygonal shape.The inside of the frame 801 may have a structure of a grid 802 as shownin FIG. 8A and 8B with the non-conductive part 803. The frame 801 may beof the same thickness as the thickness of the grid lines 802 or thethickness of the frame 801 may be thicker than the grid lines 802 in therange of 1% to 2000% or in the range of 10% to 1000% or in the range of20% to 500% or in the range of 50% to 200%. Additionally the frame 801may be thinner than the grid lines 802 in the range of 0.01 times to 20times or in the range of 0.1 times to 10 times or in the range of 0.2times to 5 times or in the range of 0.5 times to 2 times. It may be alsopossible to design the electrode such that the conductive material ofthe electrode is getting thinner from the center 804 of the electrode 13as shown in FIG. 8C. The thinning step between adjacent grid lines 802in the direction from the center 804 may be in the range of of 0.1 timesto 10 times or in the range of 0.2 times to 5 times or in the range of0.5 times to 2 times with the frame 801 having the thinnest line ofconductive material. Alternatively, the electrode may not be framed,e.g. it may have a form of a grid with no boundaries as shown in FIG.8D. A ratio of conductive to non-conductive material of the electrodemay be in the range of 1% to 99%, or in the range of 5% to 95% or in therange of 10% to 90% or in the range of 20% to 80% or in the range of 30%to 70% or in the range of 40% to 60%. Additionally the ration ofconductive to non-conductive material of the electrode may be in therange of 1% to 20%, or in the range of 10% to 40% or in the range of 33%to 67% or in the range of 50% to 70% or in the range of 66% to 100%.Such a grated electrode may be very advantageous. It may be much moreflexible, it may ensure contact with the patient that is more proper andit may have much better self-cooling properties than full-areaelectrode.

In case when the active element 13 is in the form of the gratedelectrode, the energy flux of the grated electrode may be calculated asan energy flux of the grid 802 and/or the frame 801 of the activeelement 13 and may be in the range of 0.001 W/cm² to 1500 W/cm² or 0.01W/cm² to 1000 W/cm² or 0.5 W/cm² to 500 W/cm2.

The active elements 13 may be partially embedded within the flexiblesubstrate layer 42 or adhesive layer 40 or in the interface of theflexible substrate layer 42 and adhesive layer 40. The active elements13 may be supplied and controlled independently by multiple conductiveleads 41 a or they may be conductively interconnected andsupplied/controlled via a single conductive lead 41 b. The multipleconductive leads 41 a may be connected to the active elements 13 via afree space (e.g. hole) in the flexible substrate layer 42. The freespace (e.g. hole) may have such dimensions that each conductive lead 41a may fit tightly into the substrate layer 42, e.g. the conductive lead41 a may be encapsulated by flexible substrate layer 42. In case of asingle conductive lead connection, the active elements 13 may bepartially embedded inside the flexible substrate 42 or adhesive layer 40or in the interface of the flexible substrate layer 42 and adhesivelayer 40, and the active elements 13 may be connected via singleconductive lead 41 b which may be situated in the flexible substrate 42or at the interface of the flexible substrate 42 and adhesive layer 40.The single conductive lead 41 b may leave the pad 4 on its lateral ortop side in a direction away from the patient. In both cases theconductive lead 41 a or 41b does not come into contact with thetreatment area.

Additionally, the active elements 13 may be partially embedded withinthe flexible substrate 42 and the adhesive layer 40 may surround theactive elements 13 such that a surface of active elements 13 may be atleast partially in direct contact with the surface of a treatment area.

Total pad thickness in the narrower spot may be in the range of 0.1 mmto 60 mm or in the range of 0.5 mm to 50 mm or in the range of 0.7 mm to40 mm or in the range of 1 mm to 30 mm.

The apparatus configured in a fractional arrangement may have the activeelement 13 comprising a matrix formed by active points of defined size.These points are separated by inactive (and therefore untreated) areasthat allow faster tissue healing. The surface containing active pointsmay make up from 1 to 99% or from 2 to 90% or from 3 to 80% or from 4 to75% of the whole active element area. The active points may have bluntends at the tissue contact side that do not penetrate the tissue,wherein the surface contacting tissue may have a surface area in therange of 500 μm² to 250 000 μm² or in the range of 1000 μm² to 200 000μm² or in the range of 200 μm² to 180 000 μm² or in the range of 5000μm² to 160 000 μm². The blunt end may have a radius of curvature of atleast 0.05 mm. A diameter of the surface contacting tissue of one activepoint may be in the range of 25 μm to 1500 μm or in the range of 50 μmto 1000 μm or in the range of 80 μm to 800 μm or in the range of 100 μmto 600 μm.

Additionally, the device may employ a safety system comprising thermalsensors and a circuit capable of adjusting the therapy parameters basedon the measured values. One or more thermal sensors, depending on thenumber and distribution of active elements 13, may be integrated ontopad 4 to collect data from different points so as to ensure homogeneityof heating. The data may be collected directly from the treatment areaor from the active elements 13. If uneven heating or overheating isdetected, the device may notify the operator and at the same time adjustthe therapy parameters to avoid burns to the patient. Treatmentparameters of one or more active elements might be adjusted. The maintherapy parameters are power, duty cycle and time period regulatingswitching between multiple active elements 13. Therapy may beautomatically stopped if the temperature rises above the safe threshold.

Furthermore, impedance measurement may be incorporated in order tomonitor proper active element 13 to skin contact. If the impedance valueis outside the allowed limits, the therapy may be automaticallysuspended and the operator may be informed about potential contactissues.

CPU 11 may be incorporated onto the pad 4 itself or it may form aseparate part conductively connected to the pad 4. In addition to thecontrol mechanism, CPU 11 may also contain main indicators (e.g. ongoingtherapy, actual temperature and active element to skin contact).

FIG. 5 shows some delivery approaches of apparatus for contact therapy.

It is possible to switch between multiple active elements 13 within thesingle pad 4 in such a way so that the multiple active elements 13deliver energy simultaneously, successively or in an overlapping methodor any combination thereof. For example, in the case of two activeelements: in the simultaneous method, both active elements are usedsimultaneously during the time interval e.g., 1-20 s. In the successivemethod, the first active element is used during the first time intervale.g., from 1 s to 10 s. The first active element is then stopped and thesecond active element is immediately used in a subsequent time intervale.g., from 10 s to 20 s. This successive step may be repeated. In theoverlapping method, the first active element is used during a timeinterval for e.g., 1-10 s, and the second active element is used in asecond overlapping time interval for e.g., 1-10 s, wherein during thesecond time interval the first active element and the second activeelement are overlapping e.g., with total overlapping method time of0.1-9.9 s. Active elements 13 may deliver energy sequentially inpredefined switching order or randomly as set by operator via humanmachine interface 8. Schema I in FIG. 5 represents switching betweenpairs/groups formed of non-adjacent active elements 13 located within apad 4. Every pair/group of active elements 13 is delivering energy for apredefined period of time (dark gray elements in FIG. 5—in schema Ielements 1 and 3) while the remaining pairs/groups of active elements 13remain inactive in terms of energy delivery (light gray elements in FIG.5—in schema I elements 2 and 4). After a predefined period of time,energy is delivered by another pair/group of active elements 13 and theinitial active elements become inactive. This is indicated by arrows inFIG. 5. Switching between pairs/groups of active elements 13 maycontinue until a target temperature is reached throughout the entiretreatment area or a predefined energy is delivered by all activeelements 13. Schema II in FIG. 5 represents switching of all activeelements 13 within the pad 4 between state ON when active elements aredelivering energy and OFF when they are not delivering energy. Theduration of ON and OFF states may vary depending on predefined settingsand/or information provided by sensors, e.g. thermal sensors. Schema IIIin FIG. 5 shows sequential switching of individual active elements 13within a pad 4. Each active element 13 is delivering energy forpredefined periods of time until a target temperature is reachedthroughout the entire treatment area or a predefined energy is deliveredby all active elements 13. This sequential switching may be executed ina clockwise or anticlockwise order. Schema IV in FIG. 5 represents azig-zag switching order during which preferably non-adjacent activeelements 13 deliver energy sequentially until all active elements 13within a pad 4 have been switched ON. Each active element 13 deliversenergy for a predefined period of time until a target temperature isreached throughout the entire treatment area or a predefined energy isdelivered by all active elements.

The CPU may be configured to control the stimulation device and providetreatment by at least one treatment protocol improving of visualappearance. Treatment protocol is set of parameters of the primaryelectromagnetic energy and the secondary energy ensuring the desiredtreatment effect. Each pad may be controlled to provide same oralternatively different protocol. Pair areas or areas where symmetricaleffect is desired may be treated by the same treatment protocol. Eachprotocol may include one or several sections or steps.

As a non-limiting example: in case of applying the radiofrequency energyby the active elements one by one as shown in Schema III and IV in FIG.5, the time when one active element delivers the radiofrequency energyto the tissue of the patient may be in the range of 1 ms to 10 s or inthe range of 10 ms to 5 s or in the range of 50 ms to 2 s or in therange of 100 ms to 1500 ms. Two consecutive elements may be switched ONand OFF in successive or overlapping method. Additionally, the deliveryof the radiofrequency energy by two consecutive active elements may beseparated by the time of no or low radiofrequency stimulation, such thatnon of the two consecutive active elements provides a radiofrequencyheating of the treatment tissue. The time of no or low radiofrequencystimulation may be in the range of 1 μs to 1000 ms, or in the range of500 μs to 500 ms or in the range of 1 ms to 300 ms or in the range of 10ms to 250 MS.

In case of the treatment when more than one pad is used, the sequentialswitching of the active elements providing radiofrequency treatment maybe provided within each pad independently of the other pads or activeelements may deliver energy sequentially through all pads.

As an example for three dependent pads, each with two active elements:

-   first step—the radiofrequency may be provided by active element one    in the first pad, wherein other active elements are turned off,-   second step—the active element two of the first pad is turned on and    the rest of the active elements are turned off,-   third step—the active element one of the second pad is turned on and    the rest of the active elements are turned off,-   fourth step—the active element two of the second pad is turned on    and the rest of the active elements are turned off,-   fifth step—the active element one of the third pad is turned on and    the rest of the active elements are turned off,-   sixth step—the active element two of the third pad is turned on and    the rest of the active elements are turned off

Another non-limiting example may be:

-   first step—the radiofrequency may be provided by active element one    in the first pad, wherein other active elements are turned off,-   second step—the active element one of the second pad is turned on    and the rest of the active elements are turned off,-   third step—the active element one of the third pad is turned on and    the rest of the active elements are turned off,-   fourth step—the active element two of the first pad is turned on and    the rest of the active elements are turned off,-   fifth step—the active element two of the second pad is turned on and    the rest of the active elements are turned off,-   sixth step—the active element two of the third pad is turned on and    the rest of the active elements are turned off

In case that the pads are treating pair areas (e.g. cheeks, thighs orbuttocks), where symmetrical effect is desired, the pair pads may bedriven by the same protocol at the same time.

An example of treatment protocol for one pad delivering theradiofrequency energy for heating of the patient and the electriccurrent causing the muscle contractions is as follow. The protocol mayinclude a first section where electrodes in one pad may be treated suchthat the electrodes provide an electric current pulses modulated in anenvelope of increasing amplitude modulation (increasing envelope)followed by constant amplitude (rectangle envelope) followed bydecreasing amplitude modulation (decreasing envelope), all these threeenvelopes may create together a trapezoidal amplitude modulation(trapezoidal envelope). The trapezoidal envelope may last 1 to 10seconds or 1.5 to 7 seconds or 2 to 5 seconds. The increasing,rectangle, or decreasing envelope may last for 0.1 to 5 seconds or 0.1to 4 seconds or 0.1 to 3 seconds. The increasing and decreasing envelopemay last for the same time, thus creating a symmetrical trapezoidenvelope. Alternatively, the electric current may be modulated to asinusoidal envelope or rectangular envelope or triangular envelope. Therespective envelopes causing muscle contractions may be separated bytime of no or low current stimulation, such that no muscle contractionis achieved or by a radiofrequency energy causing the heating of thetissue. During this time of no muscle contraction, the pressure massageby suction openings may be provided, which may cause the relaxation ofthe muscles. The first section may be preprogrammed such that electrodeson various places of the pad may be switched in time to providealternating current pulses wherein some other electrodes in the pad maynot provide any alternating current pulses but only RF pulses causingheating of the tissue. All electrodes in the pad may ensure providing(be switched by the switching circuitry 14 to provide) RF pulses forheating the tissue during the section of protocol or protocol, whileonly a limited amount of the electrodes may provide (be switched by theswitching circuitry 14 to provide) alternating currents for musclecontracting during the section of protocol or protocol. The device maybe configured such that the first section lasts for 1-5 minutes.

A second section may follow the first section. The second section may bepreprogrammed such that different electrodes than the ones used in thefirst section on various places of the pad may be switched in time toprovide alternating current pulses wherein some other electrodes (sameor different electrodes than the ones used in the first section) in thepad may not provide any alternating current pulses but only RF pulsescausing heating of the tissue.

A third section may follow the second section. The third section may bepreprogrammed such that different electrodes than the ones used in thesecond section on various places of the pad may be switched in time toprovide alternating current pulses wherein some other electrodes (sameor different electrodes than the ones used in the second section) in thepad may not provide any alternating current pulses but only RF pulsescausing heating of the tissue.

The protocol may be preprogrammed such, that the electrodes providingthe electric current causing the muscle contractions are switched toprovide radiofrequency heating after they produce one, two, three, fouror five contractions on maximum.

The respective sections are assembled by the control unit (CPU) in thetreatment protocol to provide at least 60-900 contractions or 90-800contractions, or 150-700 contractions by a single pad.

The forehead pad may include a layout of electrodes such that theanatomical area 1 and anatomical area 2 are stimulated by alternatingcurrents which may cause muscle contractions while anatomical area 3 isnot stimulated by alternating electric causing muscle contraction. Thecontrol unit (CPU) is configured to provide a treatment protocolenergizing by alternating electric currents only those electrodeslocated in proximity or above the anatomical area 1 and 2; andenergizing electrode/electrodes in proximity of or above anatomical area3 by radiofrequency signal only as shown in FIG. 9. The anatomical area1 and 2 may comprise the Frontalis muscles and the anatomical area 3 maycomprise the center of the Procerus muscle.

The pad used for a treatment of the cheek (either side of the face belowthe eye) may include a layout of electrodes such that the anatomicalarea comprising the Buccinator muscle, the Masseter muscle, theZygomaticus muscles or the Risorius muscle are stimulated by electricalcurrents, which may cause muscle contractions, wherein the otheranatomical area may be only heated by the radiofrequency energy.

On the contrary the pad may be configured such, that the layout ofelectrodes close to the eyes (e.g. body part comprising Orbicularisoculi muscles) or teeth (e.g. body part comprising Orbicularis orismuscles) may not provide energy causing the muscle contractions.

The treatment device may be configured such, that in each section orstep the impedance sensor provides the information about the contact ofthe pad or active element with the patient to the CPU. The CPU maydetermine based on the pre-set conditions if the contact of the pad oractive element with the patient is sufficient or not. In case ofsufficient contact, the CPU may allow the treatment protocol tocontinue. In case that the contact is inappropriate, the valuated pad oractive element is turned off and the treatment protocol continues toconsecutive pad or active element or the treatment is terminated. Thedetermination of proper contact of the pad or active element may bedisplayed on the human machine interface 8.

The impedance measurement may be made at the beginning of thesection/step, during the section/step or at the end of the section/step.The impedance measurement and/or the proper contact evaluation may bedetermined only on the active electrodes for the given section/step ormay be made on all electrodes of all pads used during the section/step.

FIG. 6 and FIG. 7 are discussed together. FIG. 6 shows a block diagramof an apparatus for contactless therapy 100. FIG. 7 is an illustrationof an apparatus for contactless therapy 100. Apparatus for contactlesstherapy 100 may comprise two main blocks: main unit 2 and a deliveryhead 19 interconnected via fixed or adjustable arm 21.

Main unit 2 may include electromagnetic generator 6 which may generateone or more forms of electromagnetic radiation wherein theelectromagnetic radiation may be e.g., in the form of incoherent lightor in the form of coherent light (e.g. laser light) of predeterminedwavelength. The electromagnetic field may be primarily generated by alaser, laser diode module, LED, flash lamp or incandescent light bulb.The electromagnetic radiation may be such that it may be at leastpartially absorbed under the surface of the skin of the patient. Thewavelength of the applied radiation may be in the range of 100 to 15000nm or in the range of 200 to 12000 nm or in the range of 300 to 11000 nmor in the range of 400 to 10600 nm or it may be in the form of second,third, fourth, fifth, sixth, seventh or eighth harmonic wavelengths ofthe above mentioned wavelength ranges. Main unit 2 may further comprisea human machine interface 8 represented by display, buttons, keyboard,touchpad, touch panel or other control members enabling an operator tocheck and adjust therapy and other device parameters. The power supply 5located in the main unit may include a transformer, disposable battery,rechargeable battery, power plug or standard power cord. The outputpower of the power supply 5 may be in the range of 10 W to 600 W, or inthe range of 50 W to 500 W, or in the range of 80 W to 450 W. Indicators17 may provide additional information about the current status of thedevice independently on human machine interface 8. Indicators 17 may berealized through the display, LEDs, acoustic signals, vibrations orother forms capable of adequate notice.

Delivery head 19 may be interconnected with the main unit via arm 21which may form the main optical and electrical pathway. Arm 21 maycomprise transmission media, for example wires or waveguide, e.g.mirrors or fiber optic cables, for electromagnetic radiation in the formof light or additional electric signals needed for powering the deliveryhead 19. The CPU 11 controls the electromagnetic generator 6 which maygenerate a continuous electromagnetic energy (CM) or a pulses, having afluence in the range of 0.1 pJ/cm² to 1000 J/cm² or in the range of 0.5pJ/cm² to 800 J/cm² or in the range of 0.8 pJ/cm² to 700 J/cm² or in therange of 1 pJ/cm² to 600 J/cm² on the output of the electromagneticgenerator. The CM mode may be operated for a time interval in the rangeof 0.1 s to 24 hours or in the range of 0.2 s to 12 hours or in therange of 0.5 s to 6 hours or in the range of 1 s to 3 hours. The pulseduration of the electromagnetic radiation operated in the pulse regimemay be in the range of 0.1 fs to 2000 ms or in the range of 0.5 fs to1500 ms or in the range of 1 fs to 1200 ms or in the range of 1 fs to1000 ms. Alternatively the pulse duration may be in the range of 0.1 fsto 1000 ns or in the range of 0.5 fs to 800 ns or in the range of 1 fsto 500 μs or in the range of 1 fs to 300 μs. Alternatively, the pulseduration may be in the range of 0.3 to 5000 ps or in the range of 1 to4000 ps or in the range of 5 to 3500 ps or in the range of 10 to 3000ps. Or alternatively the pulse duration may be in the range of 0.05 to2000 ms or in the range of 0.1 to 1500 ms or in the range of 0.5 to 1250ms or in the range of 1 to 1000 ms. The electromagnetic generator 6 inthe pulse regime may be operated by CPU 11 in a single shot mode or in arepetition mode or in a burst mode. The frequency of the repetition modeor the burst mode may be in the range of 0.05 to 10 000 Hz or in therange of 0.1 to 5000 Hz or in the range of 0.3 to 2000 Hz or in therange of 0.5 to 1000 Hz. Alternatively the frequency of the repetitionmode or the burst mode may be in the range of 0.1 kHz to 200 MHz or inthe range of 0.5 kHz to 150 MHz or in the range of 0.8 kHz to 100 MHz orin the range of 1 kHz to 80 MHz. The single shot mode may be configuredto generate a single electromagnetic energy of specific parameters (e.g.intensity, duration, etc.) for irradiation of a single treatment area.The repetition mode may be configured to generate an electromagneticenergy, which may have one or more specific parameters (e.g. intensity,duration, etc.), with a repetition rate of the above-mentioned frequencyfor irradiation of a single treatment area. The burst mode may beconfigured to generate multiple consecutive electromagnetic energys,which may have variable parameters (e.g. intensity, duration, delayetc.), during one sequence, wherein the sequences are repeated with theabove-mentioned frequency and wherein the sequence may include the sameor different sets of consecutive electromagnetic energys.

Alternatively, the device may contain more than one electromagneticgenerator 6 for generation of the same or a different electromagneticenergy, e.g. one electromagnetic generator is for generation of anablative electromagnetic energy and the other is for generation of anon-ablative electromagnetic energy. In this case, it is possible for anoperator to select which electromagnetic generators may be used for agiven treatment or the clinician can choose a required treatment throughthe human machine interface 8 and the CPU 11 will select whichelectromagnetic generators will be used. It is possible to operate oneor more electromagnetic generators of the device 100 simultaneously,successively or in an overlapping method. For example in the case of twoelectromagnetic generators: in the simultaneous method, bothelectromagnetic generators are used simultaneously during a timeinterval e.g., 1-20 ps. In the successive method, the firstelectromagnetic generator is used during the first time interval e.g.,from 1 to 10 ps. The first electromagnetic generator is then stopped andthe second electromagnetic generator is immediately used in a subsequenttime interval e.g., from 10 to 20 ps. Such a sequence of two or moresuccessive steps may be repeated. In the overlapping method, the firstelectromagnetic generator is used during a time interval, e.g., 1-10 ps,and the second electromagnetic generator is used in a second overlappingtime interval for e.g., 2-11 ps, wherein during the second time intervalthe first electromagnetic generator and the second electromagneticgenerator are overlapping e.g., with total overlapping method time for2-10 ps. In the case of more than two electromagnetic generators, theactivating and deactivating of the electromagnetic generators in asuccessive or overlap method may be driven by CPU 11 in the order whichis suitable for a given treatment, e.g. first activating the pre-heatingelectromagnetic generator, then the ablation electromagnetic generatorand then the non-ablative electromagnetic generator.

The active elements 13 in the delivery head 19 may be in the form ofoptical elements, which may be represented by one or more opticalwindows, lenses, mirrors, fibers or diffraction elements. The opticalelement representing active element 13 may be connected to or maycontain electromagnetic generator 6 inside the delivery head 19. Theoptical element may produce one beam of electromagnetic energy, whichmay provide an energy spot having an energy spot size defined as asurface of tissue irradiated by one beam of light. One light generatormay provide one or more energy spots e.g. by splitting one beam into aplurality of beams. The energy spot size may be in the range of 0.001cm² to 1000 cm², or in the range of 0.005 cm² to 700 cm², or in therange of 0.01 cm² to 300 cm², or in the range of 0.03 cm² to 80 cm².Energy spots of different or the same wavelength may be overlaid or maybe separated. Two or more beams of light may be applied to the same spotat the same time or with a time gap ranging from 0.1 μs to 30 seconds.Energy spots may be separated by at least 1% of their diameter, and inaddition, energy spots may closely follow each other or may be separatedby a gap ranging from 0.01 mm to 20 mm or from 0.05 mm to 15 mm or from0.1 mm to 10 mm.

The CPU 11 may be further responsible for switching between activeelements 13 or for moving the active elements 13 within the deliveryhead 19 so that the electromagnetic radiation may be deliveredhomogeneously into the whole treatment area marked with aiming beam 18.The rate of switching between active elements 13 may be dependent on theamount of delivered energy, pulse length, etc. and the speed of CPU 11or other mechanism responsible for switching or moving the activeelements 13 (e.g. scanner). Additionally, a device may be configured toswitch between multiple active elements 13 in such a way that theydeliver energy simultaneously, successively or in an overlapping method.For example, in the case of two active elements: in the simultaneousmethod, both active elements are used simultaneously during the timeinterval e.g., 1-20 ps. In the successive method, the first activeelement is used during the first time interval e.g., from 1 to 10 ps.The first active element is then stopped and the second active elementis immediately used in a subsequent time interval e.g., from 10 to 20ps. This successive step may be repeated. In the overlapping method, thefirst active element is used during a time interval for e.g., 1-10 ps,and the second active element is used in a second overlapping timeinterval for e.g., 2-11 ps, wherein during the second time interval thefirst active element and the second active element are overlapping e.g.,with total overlapping method time for 2-10 ps.

The aiming beam 18 has no clinical effect on the treated tissue and mayserve as a tool to mark the area to be treated so that the operatorknows which exact area will be irradiated and the CPU 11 may set andadjust treatment parameters accordingly. An aiming beam may be generatedby a separate electromagnetic generator or by the primaryelectromagnetic generator 6. Aiming beam 18 may deliver energy at awavelength in a range of 300-800 nm and may supply energy at a maximumpower of 10 mW.

In addition, the pad may contain a CPU 11 driven distance sensor 22 formeasuring a distance from active element 13 to the treated point withinthe treated area marked by aiming beam 18. The measured value may beused by CPU 11 as a parameter for adjusting one or more treatmentparameters which may depend on the distance between an electromagneticgenerator and a treating point, e.g. fluence. Information from distancesensor 22 may be provided to CPU 11 before every switch/movement of anactive element 13 so that the delivered energy will remain the sameacross the treated area independent of its shape or unevenness.

The patient's skin may be pre-cooled to a selected temperature for aselected duration over at least one treatment portion, the selectedtemperature and duration for pre-cooling preferably being sufficient tocool the skin to at least a selected temperature below normal bodytemperature. The skin may be cooled to at least the selected temperatureto a depth below the at least one depth for the treatment portions sothat the at least one treatment portion is substantially surrounded bycooled skin. The cooling may continue during the application ofradiation, wherein the duration of the application of radiation may begreater than the thermal relaxation time of the treatment portions.Cooling may be provided by any known mechanism including water cooling,sprayed coolant, presence of an active solid cooling element (e.g.thermoelectric cooler) or air flow cooling. A cooling element may act asan optical element. Alternatively, a spacer may serve as a coolingelement. Cooling may be provided during, before or after the treatmentwith electromagnetic energy. Cooling before treatment may also providean environment for sudden heat shock, while cooling after treatment mayprovide faster regeneration after heat shock. The temperature of thecoolant may be in the range of −200° C. to 36° C. The temperature of thecooling element during the treatment may be in the range of −80° C. to36° C. or −70° C. to 35° C. or −60° C. to 34° C. Further, where the padis not in contact with the patient's skin, cryogenic spray cooling, gasflow or other non-contact cooling techniques may be utilized. A coolinggel on the skin surface might also be utilized, either in addition to orinstead of, one of the cooling techniques indicated above.

Additionally, device 100 may include one or more sensors. The sensor mayprovide information about at least one physical quantity and itsmeasurement may lead to feedback which may be displayed by human machineinterface 8 or indicators 17. The one or more sensors may be used forsensing a variety of physical quantities, including but not limited tothe energy of the delivered electromagnetic radiation or backscatteredelectromagnetic radiation from the skin, impedance of the skin,resistance of the skin, temperature of the treated skin, temperature ofthe untreated skin, temperature of at least one layer of the skin, watercontent of the device, the phase angle of delivered or reflected energy,the position of the active elements 13, the position of the deliveryelement 19, temperature of the cooling media or temperature of theelectromagnetic generator 6. The sensor may be a temperature, acoustic,vibration, electric, magnetic, flow, positional, optical, imaging,pressure, force, energy flux, impedance, current, Hall or proximitysensor. The sensor may be a capacitive displacement sensor, acousticproximity sensor, gyroscope, accelerometer, magnetometer, infraredcamera or thermographic camera. The sensor may be invasive orcontactless. The sensor may be located on the delivery element 19 or inthe main unit 2 or may be a part of a distance sensor 22. One sensor maymeasure more than one physical quantity. For example, a sensor mayinclude a combination of a gyroscope, an accelerometer or amagnetometer. Additionally, the sensor may measure one or more physicalquantities of the treated skin or untreated skin.

The temperature sensor measures and monitors the temperature of thetreated skin. The temperature can be analyzed by a CPU 11. Thetemperature sensor may be a contactless sensor (e.g. infraredtemperature sensor). The CPU 11 may also use algorithms to calculate atemperature below the surface of the skin based on the surfacetemperature of the skin and one or more additional parameters. Atemperature feedback system may control the temperature and based on setor pre-set limits alert the operator in human perceptible form e.g. onthe human machine interface 8 or via indicators 17. In a limittemperature condition, the device may be configured to adjust treatmentparameters of each active element, e.g. output power, activate coolingor stop the treatment. Human perceptible form may be a sound, alertmessage shown on human machine interface 8 or indicators 17 or change ofcolor of any part of the device 100.

A resistance sensor may measure the skin resistance, since it may varyfor different patients, as well as the humidity—wetness and sweat mayinfluence the resistance and therefore the behavior of the skin in theenergy field. Based on the measured skin resistance, the skin impedancemay also be calculated.

Information from one or more sensors may be used for generation of apathway on a convenient model e.g. a model of the human body shown on adisplay of human machine interface 8. The pathway may illustrate asurface or volume of already treated tissue, presently treated tissue,tissue to be treated, or untreated tissue. A convenient model may show atemperature map of the treated tissue providing information about thealready treated tissue or untreated tissue.

The sensor may provide information about the location of bones, inflamedtissue or joints. Such types of tissue may not be targeted byelectromagnetic radiation due to the possibility of painful treatment.Bones, joints or inflamed tissue may be detected by any type of sensorsuch as an imaging sensor (ultrasound sensor, IR sensor), impedance andthe like. A detected presence of these tissue types may cause generalhuman perceptible signals or interruption of generation ofelectromagnetic radiation. Bones may be detected for example by a changeof impedance of the tissue or by analysis of reflected electromagneticradiation.

Furthermore, the device 100 may include an emergency stop button 16 sothat the patient can stop the therapy immediately anytime during thetreatment.

It may be part of the invention that the method of treatment includesthe following steps: preparation of the tissue; positioning the proposeddevice; selecting or setting up the treatment parameters; andapplication of the energy. More than one step may be executedsimultaneously.

Preparation of the tissue may include removing make-up or cleansing thepatient's skin. For higher target temperatures, anesthetics may beapplied topically or in an injection.

Positioning the device may include selecting the correct shape of thepad according to the area to be treated and affixing the pad or theneutral electrode to the patient, for example with an adhesive layer,vacuum suction, band or mask, and verifying proper contact with thetreated tissue in the case of contact therapy. In the case ofcontactless therapy, positioning of the device may include adjusting theaiming beam of proposed device so that the device can measure thedistance of the active element(s) from the treatment area and adjust thetreatment parameters accordingly.

Selecting or setting up the treatment parameters may include adjustingtreatment time, power, duty cycle, delivery time and mode (CM orpulsed), active points surface density/size for fractional arrangementand mode of operation. Selecting the mode of operation may mean choosingsimultaneous, successive or overlapping methods or selecting theswitching order of active elements or groups of active elements orselecting the proper preprogrammed protocol.

Application of the energy may include providing at least one type ofenergy in the form of RF energy, ultrasound energy or electromagneticenergy in the form of polychromatic or monochromatic light, or theircombination. The energy may be provided from at least one active elementinto the skin by proposed device. Energy may be delivered and regulatedautomatically by the CPU according to information from temperaturesensors and impedance measurements and, in the case of contactlesstherapy, distance sensors. All automatic adjustments and potentialimpacts on the therapy may be indicated on the device display. Eitherthe operator or the patient may suspend therapy at any time duringtreatment. A typical treatment might have a duration of about 1 to 60min or 2 to 50 min or 3 to 40 min per pad depending on the treated areaand the size and number of active elements located within the pad.

In one example, application of energy to the tissue may includeproviding radiofrequency energy or ultrasound energy or theircombination, from the active elements embedded in the pad, to the skinof the patient. In such case, active elements providing radiofrequencyenergy may be dielectric and capacitive or resistive RF electrodes andthe RF energy may cause heating, coagulation or ablation of the skin.Ultrasound energy may be provided through an acoustic window and mayrise the temperature in the depth which may suppress the gradient lossof RF energy and thus the desired temperature in a germinal layer may bereach. In addition, the RF electrode may act as an acoustic window forultrasound energy.

Alternatively, the application of the energy to the tissue may includeproviding electromagnetic energy in the form of polychromatic ormonochromatic light from the active elements into the skin of thepatient. In such case, active elements providing the electromagneticenergy may comprise optical elements described in the proposed device.Optical elements may be represented by an optical window, lens, mirror,fiber or electromagnetic field generator, e.g. LED, laser, flash lamp,incandescent light bulb or other light sources known in the state ofart. The electromagnetic energy in the form of polychromatic ormonochromatic light may entail the heating, coagulation or ablation ofthe skin in the treated area.

After reaching the required temperature and therapy time the therapy isterminated, the device accessories may be removed and a cleansing of thepatient's skin may be provided.

1. A device for improving a visual appearance of a patient, comprising:a pad comprising a plurality of electrodes, the plurality of electrodescomprising a plurality of radiofrequency electrodes and at least onepair of electrotherapy bipolar electrodes; wherein the pad and theplurality of electrodes are configured to be fixedly attached to a bodypart of the patient during a single treatment; a control unit configuredto control the plurality of electrodes; wherein the plurality ofradiofrequency electrodes are configured to apply a radiofrequencyenergy with a frequency in a range of 400 kHz to 80 MHz to the body partof the patient, causing a radiofrequency heating of a skin of the bodypart to a temperature in a range of 37.5° C. to 65° C.; wherein the atleast one pair of electrotherapy bipolar electrodes is configured toapply a pulsed electric current with a pulse duration in a range of 0.1μs to 10 s and a frequency in a range of 0.1 Hz to 12 kHz to the bodypart, causing an electric muscle stimulation and contraction of a musclewithin the body part, wherein a distance between the at least one pairof electrotherapy bipolar electrodes is in a range of 0.1 mm to 4 cm,wherein the muscle within the body part comprises at least one offrontalis muscle, buccinator muscle, masseter muscle, zygomaticusmuscle, and risorius muscle, and wherein the pad is configured toprovide the radiofrequency heating and the electric muscle stimulationduring the single treatment in order to improve the visual appearance ofthe patient.
 2. The device of claim 1, wherein the plurality ofradiofrequency electrodes provides the radiofrequency energy in a pulsemode; wherein a pulse duration of a radiofrequency energy delivery is ina range of 0.1 ms to 10 s.
 3. The device of claim 2, wherein theradiofrequency energy is provided successively by first and secondradiofrequency electrodes of the plurality of radiofrequency electrodes;and wherein the providing of the radiofrequency energy by the first andsecond radiofrequency electrodes is separated by a time of noradiofrequency stimulation having a duration in a range of 1 μs to 1000ms.
 4. The device of claim 3, wherein the pulsed electric current ismodulated in an amplitude creating a trapezoidal envelope.
 5. The deviceof claim 4, wherein the trapezoidal envelope is a symmetricaltrapezoidal envelope with a duration in a range of 1 second to 10seconds.
 6. The device of claim 5, wherein the pad is configured toprovide the radiofrequency energy and the electric currentsimultaneously for at least a subset of a duration of the treatment. 7.The device of claim 6, wherein the envelope is repeated at a frequencyin a range of 0.1 Hz to 140 Hz.
 8. A device for improving a visualappearance of a patient, comprising: a pad comprising at least oneradiofrequency electrode and at least one electrotherapy electrode;wherein the pad is flexible; and wherein the pad is configured to befixedly attached to at least one of a face, a submentum, or a neck ofthe patient during a single treatment; the at least one radiofrequencyelectrode configured to apply a radiofrequency energy with a frequencyin a range of 400 kHz to 80 MHz to at least one of the face, thesubmentum, or the neck, causing a radiofrequency heating of a skin of atleast one of the face, the submentum, or the neck to a temperature in arange of 37.5° C. to 65° C.; the at least one electrotherapy electrodeconfigured to apply a pulsed electric current with a pulse duration in arange of 0.5 μs to 500 ms to at least one of the face, the submentum, orthe neck, causing a contraction of a muscle within at least one of theface, the submentum, or the neck; a control unit configured to controlthe at least one radiofrequency electrode and the at least oneelectrotherapy electrode; wherein the control unit comprises a centralprocessing unit or a microprocessor; and wherein the control unit isconfigured to control the pad to provide the radiofrequency energy andthe electric current during a single treatment in order to improve thevisual appearance of the patient.
 9. The device of claim 8, wherein thepulsed electric current is an alternating current with a frequency in arange of 0.5 Hz to 1 kHz.
 10. The device of claim 9, wherein the pulsedelectric current is provided with a trapezoidal envelope; wherein thetrapezoidal envelope has an envelope duration in a range of 1 second to10 seconds; and wherein a duration of an increasing or a decreasing partof the trapezoidal envelope is in a range of 0.1 s to 5 s.
 11. Thedevice of clam 10, further comprising an impedance sensor configured toobtain an information about a contact of the pad or the at least oneradiofrequency electrode or the at least one electrotherapy electrodewith the patient; and wherein the impedance sensor is configured toprovide the information about the contact to the control unit.
 12. Thedevice of claim 11, further comprising a user interface; and the controlunit further comprising one or more preprogrammed treatment protocolsfor improvement of the visual appearance of the patient; wherein the oneor more preprogrammed treatment protocols are configured to be selectedby a user of the device via the user interface.
 13. The device of claim12, wherein the one or more treatment protocols comprise sections;wherein each section includes a specific set of parameters of theradiofrequency energy and the electric current; and wherein theimpedance sensor is configured to provide the information about thecontact of the pad or the at least one radiofrequency electrode or theat least one electrotherapy electrode with the patient to the controlunit in each section of the one or more preprogrammed treatmentprotocols.
 14. The device of claim 13, wherein the sections areassembled by the control unit to induce 60 to 900 contractions by thepad during the single treatment.
 15. The device of claim 14, wherein thepad is configured to induce the contractions in at least one muscle offrontalis muscle, buccinator muscle, masseter muscle, zygomaticus muscleor risorius muscle.
 16. A device for improving a visual appearance of apatient, comprising: a pad comprising a flexible substrate, at least oneflexible electrode and at least one conductive lead; wherein the atleast one electrode is positioned on an underside of the flexiblesubstrate; wherein the at least one conductive lead is positioned on atop side of the flexible substrate and is connected to the at least oneelectrode via a hole in the flexible substrate which is located over theat least one electrode; wherein the pad is flexible and configured to beadaptable to a body part of the patient; and wherein the underside ofthe flexible substrate and the at least one electrode are configured tobe fixedly attached to the body part and wherein the at least oneelectrode is in contact with the body part during a treatment; and acontrol unit comprising a CPU or a microprocessor, the control unitconfigured to control the at least one electrode; wherein the at leastone electrode is configured to apply a radiofrequency energy with afrequency in a range of 400 kHz to 80 MHz to the body part, causing aradiofrequency heating of a skin of the body part to a temperature in arange of 37.5° C. to 65° C.; and wherein the at least one electrode isconfigured to apply a pulsed electric current with a pulse duration in arange of 0.1 μs to 10 s and a frequency in a range of 0.1 Hz to 12 kHzto the body part, causing a muscle contraction within the body part;wherein the body part comprises a face, a submentum, or a neck; andwherein the at least one electrode is configured to apply theradiofrequency energy and the pulsed electric current during thetreatment in order to improve the visual appearance of the patient. 17.The device of claim 16, further comprising an adhesive layer on theunderside of the pad; wherein the at least one electrode is embedded inthe adhesive layer; and wherein the pad is fixedly attached to the bodypart by the adhesive layer.
 18. The device of claim 17, wherein theadhesive layer comprises a hydrogel or an adhesive tape.
 19. The deviceof claim 18, wherein the hydrogel is at least one of: a polymer matrix;a mixture containing water, a polyvinylpyrrolidone, a polyisocyanatecomponent, or a polyol component; or a hydrogel having a methylenediphenyl structure in a main chain.
 20. The device of claim 18, whereinthe impedance of the hydrogel is higher than an impedance of the skin bya factor in a range of 1.1 to 20 times.
 21. The device of claim 18,wherein the pad further comprises a sticker on the top side of theflexible substrate; wherein a bottom side of the sticker comprises asticking layer configured to provide additional contact of the pad tothe body part of the patient.
 22. The device of claim 19, wherein thesticker has a dimension exceeding a corresponding dimension of the padin a range of 0.1 cm to 10 cm.
 23. The device of claim 22, wherein thepad has a thickness in a range of 0.1 mm to 60 mm; and wherein theflexible substrate comprises at least one of a polymer-based material,polyimide film, polytetrafluoroethylene, epoxy, polyethyleneterephthalate, polyamide, PE foam, silicone based material or a fabric.24. A device for improving a visual appearance of a patient, comprising:a flexible pad comprising a flexible substrate and a plurality ofelectrodes, the plurality of electrodes comprising at least oneradiofrequency electrode and at least one pair of electrotherapy bipolarelectrodes; wherein the plurality of electrodes are positioned on anunderside of the flexible substrate; wherein each conductive lead of aplurality of conductive leads is connected to exactly one respectiveelectrode from the plurality of electrodes; wherein the pad is flexibleand configured to be adaptable to a body part of the patient; andwherein the underside of the flexible substrate and the plurality ofelectrodes are configured to be fixedly attached to the body part andwherein the plurality of electrodes are in contact with the body partduring a single treatment; a control unit comprising a CPU or amicroprocessor, the control unit configured to control the plurality ofelectrodes; wherein the at least one radiofrequency electrode isconfigured to apply a radiofrequency energy with a frequency in a rangeof 400 kHz to 80 MHz to the body part, causing a radiofrequency heatingof a skin of the body part in a range of 37.5° C. to 65° C.; wherein theat least one pair of electrotherapy bipolar electrodes is configured toapply a pulsed electric current with a pulse duration in a range of 0.1μs to 10 s and a frequency in a range of 0.1 Hz to 12 kHz to the bodypart, causing a muscle contraction within the body part; and wherein adistance between the at least one pair of electrotherapy bipolarelectrodes is in a range of 0.1 mm to 4 cm; wherein the body partcomprises a face, a submentum, or a neck; and wherein the pad isconfigured to apply the radiofrequency energy and the pulsed electriccurrent during the single treatment in order to improve the visualappearance of the patient.
 25. The device of claim 24, wherein the padhas an annular, semicircular, elliptical, oblong, square, rectangular,trapezoidal or polygonal shape configured to cover at least part of oneor more of a periorbital area, a forehead, a jaw line, a perioral area,left or right cheek or submentum of the patient.
 26. The device of claim25, wherein a surface area of the pad is in a range of 0.1 cm² to 150cm².
 27. The device of claim 26, wherein the pad has a shape of a convexor a concave polygon with one or more curvatures having a shape of anarc with a curvature k in a range of 0.002 mm⁻¹ to 10 mm⁻¹.
 28. Thedevice of claim 27, wherein each electrode from the plurality ofelectrodes has a surface area in a range from 0.1 cm² to 70 cm².
 29. Thedevice of claim 28, wherein the pad has a T shape for a treatment of theforehead; and wherein the at least one pair of electrotherapy bipolarelectrodes positioned on the pad is configured to induce a contractionof a frontalis muscle.
 30. The device of claim 28, wherein the pad has abanana shape or a horseshoe shape for a treatment of the left or rightcheek; and wherein the at least one pair of electrotherapy bipolarelectrodes positioned on the pad is configured to induce the contractionof at least one of a buccinator muscle, masseter muscle, zygomaticusmuscle or risorius muscle.